quality systems specialist

Relativity Space

<div><div><p>At Relativity Space, we're building rockets to serve today's needs and tomorrow's breakthroughs. Our Terran R vehicle will deliver customer payloads to orbit, meeting the growing demand for launch capacity. But that's just the start. Achieving commercial success with Terran R will unlock new opportunities to advance science, exploration, and innovation, pioneering progress that reaches beyond the known.</p>
<p>
Joining Relativity means becoming part of something where autonomy, ownership, and impact exist at every level. Here, you're not just executing tasks; you're solving problems that haven't been solved before, helping develop a rocket, a factory, and a business from the ground up. Whether you're in propulsion, manufacturing, software, avionics, or a corporate function, you'll collaborate across teams, shape decisions, and see your work come to life in record time. Relativity is a place where creativity and technical rigor go hand in hand, and your voice will help define the stories we're writing together. Now is a unique moment in time where it's early enough to leave your mark on the product, the process, and the culture, but far enough along that Terran R is tangible and picking up momentum. The most meaningful work of your career is waiting. Join us.</p></div><p><b>
About the Team:</b></p>
<p>
The Reliability team at Relativity Space ensures quality is built into every stage of the Terran R design and production process, embedding reliability from the very beginning. The team works directly with design, manufacturing, test, and launch teams to stay close to the hardware, understand constraints, and proactively shape decisions. As the program moves from development into production and scaled operations, this is the time to establish the right processes, controls, and inspections without slowing progress. The team plays a key role in balancing risk, fostering a culture of ownership, and making sure speed never comes at the cost of reliability. Success means creating a quality system that scales with the Terran R program and Relativity as a whole.</p>
<p><b>
About the Role:</b></p>
<ul>
<li>Configuration Identification &amp; Control: Define and maintain product configuration baselines (requirements, design, BOMs, software, and documentation), including part numbering, document control, and revision schemes to ensure alignment between engineering and manufacturing.</li>
<li>Change Management: Administer ECOs, deviations, and change requests; facilitate CCB activities; and evaluate impacts to quality, compliance, cost, and schedule while ensuring proper approvals and implementation tracking.</li>
<li>Documentation &amp; Data Management: Maintain accurate, traceable configuration records across PLM, ERP, and QMS systems with robust version control, archival, and retrieval processes.</li>
<li>Audit &amp; Traceability Support: Provide complete configuration histories and change documentation to support internal and external audits.</li>
<li>Compliance &amp; Quality Systems: Ensure configuration management practices comply with applicable standards and internal procedures; contribute to CM process development, documentation, and KPI monitoring.</li>
<li>Cross-Functional Collaboration: Partner with engineering, manufacturing, quality, and supply chain teams to support controlled product releases, NPI activities, and adoption of CM best practices.</li>
</ul>
<p><b>About You:</b></p>
<ul>
<li>Bachelor's degree in engineering, quality, or related STEM field
</li><li>5+ years of experience in quality systems or quality engineering, familiar with QMS platforms and digital applications, preferably in aerospace
</li><li>In-depth working experience of AS9100 or ISO9001 requirements and principles.
</li><li>Strong skills in document control, process mapping, and continuous improvement.</li>
</ul><div><p><b>
We are an equal opportunity employer and value diversity at our company. We do not discriminate on the basis of race, religion, color, national origin, gender, sexual orientation, age, marital status, veteran status, or disability status.</b></p>
<p><b><i>
If you need a reasonable accommodation, please contact us at </i></b><b><i>accommodations@relativityspace.com</i></b><b><i>.</i></b></p></div></div><p></p>

Quality Systems Engineering Specialist

PakLab

<p><b>Job Overview</b></p><p>The Quality Specialist supports the effective implementation, maintenance, and continuous improvement of PakLab&rsquo; s Quality Management System (QMS). This role is responsible for ensuring that company operations, documentation, and product-related activities consistently meet internal quality standards, customer expectations, and applicable regulatory and Good Manufacturing Practice (GMP) requirements. This position supports all quality system processes including but not limited to internal audits, deviation and nonconformance tracking, corrective and preventive actions (CAPA), change control, training documentation, external, and supplier audit. The Quality Specialist assists in monitoring compliance through routine review of quality data, participation in inspections and audits, and follow-up on all committed actions to ensure timely and effective resolution to the identified issues. The role works cross-functionally with Operations, Production, Regulatory, R&amp;D, and Supply Chain teams to help maintain compliance, support investigations, resolve quality issues, and ensure that quality considerations are appropriately integrated into operational processes. The Quality Specialist is expected to help communicate quality requirements clearly and support teams in understanding and adhering to established procedures and regulatory expectations.I. Essential Duties and</p><p><b>Responsibilities</b></p><ul><li>Maintain and update quality system documentation, including SOPs, work instructions, and records.</li><li>Support internal audit programs by preparing schedules, conducting audits, and documenting findings.</li><li>Support external audits by preparing, staging, and follow up on committed actions.</li><li>Assist with supplier qualification, monitoring, and audits.</li><li>Review of CAPA records, deviation reports, Nonconformance records, and change controls for accuracy and compliance.</li><li>Support investigations of non-conformances, customer complaints, and product quality issues.</li><li>Assist with CAPA (Corrective and Preventive Actions) development, implementation, and verification.</li><li>Track and report quality metrics and performance trends to direct management.</li><li>Participate in training and onboarding of employees on GMP, quality procedures, and compliance requirements.</li><li>Ensure compliance with applicable GMP, FDA, ISO, and customer-specific requirements.</li><li>Support preparation for customer and regulatory audits, including FDA and ISO.</li><li>Identify opportunities for process improvements and contribute to continuous improvement initiatives.</li><li>Perform other duties as assigned.</li></ul><p><b>Required Skills and Abilities</b></p><ul><li>Strong knowledge of GMP, quality systems, and regulatory compliance requirements.</li><li>Excellent organizational, recordkeeping, and documentation control skills.</li><li>Strong analytical and problem-solving skills with attention to detail.</li><li>Effective communication and collaboration skills across departments.</li><li>Proficiency in Microsoft Office Suite and experience with quality management systems (QMS).</li><li>Ability to manage multiple priorities and deadlines in a fast-paced environment.</li><li>Experience in a high traffic Contract manufacturer preferred.</li></ul><p><b>Education and Experience Requirements</b></p><ul><li>Bachelor&rsquo;s degree in Quality, Life Sciences, Engineering, or related field preferred.</li><li>3&ndash;5 years of hands-on quality assurance and quality systems experience in a manufacturing environment.</li><li>Experience in cosmetics, pharmaceuticals, or consumer packaged goods preferred.</li><li>Experience supporting audits and compliance programs required.</li></ul><p><b>Working Conditions and Physical Demands</b></p><ul><li>Work performed in both office and manufacturing environments.</li><li>Exposure to noise, machinery, chemicals, and production materials when on the production floor.</li><li>Flexibility to work extended hours, weekends, or shifts to meet business needs and audit schedules.</li><li>Prolonged periods of sitting at a desk and working on a computer.</li><li>Frequent walking and standing on the production floor.</li><li>Ability to lift up to 25 pounds occasionally.</li></ul><p><b>Other Duties</b></p><p>Please note this job description is not designed to cover or contain a comprehensive listing of activities, duties, or responsibilities required of the employee. Duties, responsibilities, and activities may change at any time, with or without notice.</p><p><b>Equal Employment Opportunity (EEO) Statement</b></p><p>Universal Packaging Systems, Inc. DBA PakLab is an Equal Opportunity Employer. We do not discriminate based on race, color, religion, creed, sex (including pregnancy, childbirth, breastfeeding, or related medical conditions), sexual orientation, gender identity, gender expression, national origin, ancestry, age, physical or mental disability, medical condition, genetic information, marital status, military or veteran status, or any other characteristic protected by applicable federal, state, or local law.</p><p>Pay: $57,600.00 - $66,000.00 per year</p><p>Benefits:</p><ul><li>401(k)</li><li>Dental insurance</li><li>Health insurance</li><li>Health savings account</li><li>Paid time off</li><li>Vision insurance</li></ul><p>Work Location: In person</p>

Quality and Regulatory Specialist

<p><b>Job Summary</b><br/>The Quality &amp; Regulatory Senior Specialist plays a critical role in supporting PakLab&rsquo;s Quality and Regulatory organization through the oversight, maintenance, and continuous improvement of the PakLab Quality Management System (QMS). This role ensures that company operations, products, and documentation consistently meet internal quality standards, customer expectations, and all applicable regulatory requirements.The position is responsible for managing and supporting key quality and regulatory processes including, but not limited to, training program administration, internal and external audits, customer complaint investigations, validation and qualification activities, change control, deviation and CAPA management, regulatory documentation requests, label and artwork review, regulatory licensing and registrations, and formal regulatory correspondence.</p><p>The Sr. Specialist is expected to ensure that all quality records are complete, accurate, inspection-ready, and maintained in accordance with Good Manufacturing Practices (GMP) and company procedures. In this role, the individual will act as a subject matter expert for quality and regulatory compliance, providing guidance to cross-functional teams and helping ensure that business decisions appropriately consider regulatory and quality risk. The Sr. Specialist will work closely with Operations, Production, Regulatory Affairs, R&amp;D, Supply Chain, and Commercial teams to proactively identify compliance risks, resolve quality issues, support product lifecycle activities, and implement effective corrective and preventive actions when required.</p><p>The position requires a hands-on, detail-oriented professional who can operate both tactically and strategically within the organization. Beyond routine QMS management, the Sr. Specialist is expected to actively contribute to process improvement initiatives, quality culture development, and operational excellence efforts. This includes supporting the development and monitoring of Key Performance Indicators (KPIs), trending quality data, identifying systemic issues, and recommending improvements to strengthen the overall effectiveness of the Quality Management System.</p><p>The Quality &amp; Regulatory Sr. Specialist is also expected to maintain a high level of inspection readiness, supporting regulatory inspections, customer audits, and internal assessments. The role requires strong organizational, analytical, and communication skills, as well as the ability to clearly articulate regulatory expectations and quality requirements to stakeholders across the organization.Ultimately, this position plays an important role in ensuring that PakLab maintains a robust, compliant, and continuously improving quality system, while supporting the organization&rsquo;s commitment to product safety, regulatory compliance, and customer satisfaction.</p><p><b>Essential Duties and Responsibilities</b></p><ul><li>Maintain and manage overall QMS processes and documentation.</li><li>Manage the internal audit program by preparing schedules, conducting audits, and documenting findings.</li><li>Manage and host the external audit program including preparation, staging, hosting, and corresponding.</li><li>Support and oversee supplier qualification, monitoring, and audits.</li><li>Review customer complaint reports, audit response reports, and change control reports for accuracy and compliance.</li><li>Manage and support investigations of non-conformances, customer complaints, and product quality issues.</li><li>Manage and support CAPA (Corrective and Preventive Actions) development, implementation, and verification.</li><li>Track and report quality metrics and performance trends to management.</li><li>Participate in training and onboarding of employees on GMP, quality procedures, and compliance requirements.</li><li>Manage and oversee document control system and training compliance.</li><li>Ensure compliance with applicable GMP, FDA, ISO for drugs and cosmetics as well as customer-specific requirements.</li><li>Oversee and support preparation for customer and regulatory audits, including FDA and ISO.</li><li>Identify opportunities for process improvements and contribute to continuous improvement initiatives.</li><li>Perform other duties as assigned.</li></ul><p><b>Required Skills and Abilities</b></p><ul><li>Strong knowledge of FDA drug and cosmetic requirements, ISO 22716, CGMP, quality systems, and regulatory compliance requirements.</li><li>Excellent organizational, recordkeeping, and documentation control skills.</li><li>Strong analytical and problem-solving skills with attention to detail.</li><li>Effective communication and collaboration skills across departments.</li><li>Proficiency in Microsoft Office Suite and hands on experience with quality management systems (QMS).</li><li>Ability to manage multiple priorities and deadlines in a fast-paced environment.</li><li>Self-starter, out of box thinker, and a change agent advocate .</li></ul><p><b>Education and Experience Requirements</b></p><ul><li>Bachelor&rsquo;s degree in Quality, Life Sciences, Engineering, or related field preferred.</li><li>5-7 years of hands on regulatory compliance , quality assurance, and quality systems experience in a high volume manufacturing environment.</li><li>Experience in cosmetics, pharmaceuticals, or consumer packaged goods required.</li><li>Experience supporting audits and compliance programs required.</li></ul><p><b>Physical Demands and Working Conditions</b></p><ul><li>Prolonged periods of sitting at a desk and working on a computer.</li><li>Frequent walking and standing on the production floor.</li><li>Ability to lift up to 25 pounds occasionally.</li><li>Onsite working hours in core business hours.</li><li>Work performed in both office and manufacturing environments.</li><li>Exposure to noise, machinery, chemicals, and production materials when on the production floor.</li><li>Flexibility to work extended hours, weekends, or shifts to meet business needs and audit schedules.</li></ul><p><b>Other Duties</b></p><p>Please note this job description is not designed to cover or contain a comprehensive listing of activities, duties, or responsibilities required of the employee. Duties, responsibilities, and activities may change at any time, with or without notice.</p><p><b>Equal Employment Opportunity (EEO) Statement</b></p><p>Universal Packaging Systems, Inc. DBA PakLab is an Equal Opportunity Employer. We do not discriminate based on race, color, religion, creed, sex (including pregnancy, childbirth, breastfeeding, or related medical conditions), sexual orientation, gender identity, gender expression, national origin, ancestry, age, physical or mental disability, medical condition, genetic information, marital status, military or veteran status, or any other characteristic protected by applicable federal, state, or local law.</p><p>Pay: $95,000.00 - $110,000.00 per year</p><p>Benefits:</p><ul><li>401(k)</li><li>Dental insurance</li><li>Health insurance</li><li>Health savings account</li><li>Vision insurance</li></ul><p>Work Location: In person</p>

Senior Quality and Regulatory Specialist

Glanbia Nutritionals

<div><div><b>Quality Assurance Specialist</b></div><div></div><div><b><br>
Join this dynamic team focused on delivering better nutrition for every step of life&rsquo;s journey</b>!</div><div></div><div><b><br>
The Opportunity</b></div><div>
The Quality Assurance (QA) Specialist is responsible for supporting the implementation of Quality Systems across the GNNA network and for providing support to the Quality Assurance and Quality Control team at the Carlsbad facility. This individual will operate in a fast-paced, dynamic environment and is expected to manage multiple tasks on a tight timeline to meet customer requests.</div><div></div><div><b><br>
Essential Functions and Responsibilities</b></div><ul><li>
Certified SQF Practitioner. Maintain current Food Safety &amp; Quality Programs.</li><li>
Manage and trend key QMS programs (EMP, CAPA, Sanitation, Pest Control, auditing, etc.)</li><li>
Performs floor QA duties, as necessary. In the absence of the QA Supervisor, cover for him/her.</li><li>
Work with QA Manager and Supervisor to develop and revise technical documents such as Standard Operating Procedures, Specifications, SDS, Allergen Statements, GMO Statements, Irradiation/ETO Statements, etc.</li><li>
Assist in creation and revision of Standard Operating Procedures and Step Action Guides to support Quality Systems.</li><li>
Generate various QMS related reports as required.</li><li>
Key user of CAPA (Intelex) system.</li><li>
Conduct root cause analysis and corrective/preventive action. Maintain the CAPA program ensuring CARs are closed out in a timely manner.</li><li>
Manage customers request for shelf-life extension in a timely manner.</li><li>
Perform verification / validation activities associated with the SQF system.</li><li>
Prepare and review initial responses to internal and external audits.</li><li>
Develop action plans and timelines for performing the audit corrective actions in coordination with all departments in the organization.</li><li>
Perform other duties as assigned.</li></ul><div></div><div><b><br>
What You Will Bring To The Team</b></div><ul><li>
Bachelors degree in Engineering, Chemistry, Biology or Food Science preferred.</li><li>
Active SQF certification</li><li>
Minimum of 3 years of experience in a Quality related role.</li><li>
Exposure to audits (performing, conducting, participating).</li><li>
Quality Systems exposure (Document Control, Change Control, NCRs, CAPA, etc.)</li><li>
Good verbal and written communication skills.</li><li>
Ability to work with minimal supervision while remaining productive at all times.</li><li>
Ability to stay positive and calm in difficult and/or trying circumstances.</li><li>
Ability to effectively interact with all levels of personnel.</li><li>
Ability to write routine reports and correspondence.</li><li>
Must be assertive and be able to enforce procedures and call out deviations appropriately.</li><li>
Must have excellent problem-solving skills.</li><li>
Must be able to follow written SOPs / work instructions.</li><li>
Must be able to work in a team environment and work to resolve issues.</li><li>
Must be results-oriented and strive to meet team and organizational goals.</li><li>
Working knowledge of HACCP, SQF (or any GFSI recognized food safety management programs.</li><li>
Proficiency in spoken and written English.</li><li>
Strong SAP knowledge.</li><li>
Proficient with MS Word, Excel, Outlook, PowerPoint and SharePoint.</li></ul><div></div><div><b><br>
Where You Will Work</b></div><div>
The opportunity will be based at our facility in Carlsbad, CA.</div><div></div><div><b><br>
What We Would Like To Offer You</b></div><div>
The opportunity to develop your career on a global stage, continuous learning through an on-demand learning platform, and a competitive compensation package including staff discounts, generous family leave policy, health &amp; dental plan, competitive salary, 401K.</div><div></div><div><b><br>
Physical Demands and Requirements</b></div><div><i>
The physical demands described represent those that must be met by an employee and the work environment characteristics are those an employee encounters while performing the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.</i></div><ul><li>
Regularly involves talking or listening, sitting, and the use of hands and fingers.</li><li>
Regularly involves going up and down stairs.</li><li>
Frequently involves reaching with hands and arms, standing and walking.</li><li>
Occasionally involves crouching, stooping, kneeling and/or climbing or balancing.</li></ul><ul><li>
Must be able to lift and carry items weighing up to 20 pounds.</li><li>
Manual dexterity sufficient to reach/handle items, works with the fingers, and perceives attributes of objects and materials.</li><li>
Involves moderate physical activity performing non-strenuous daily activities of a primarily administrative nature.</li><li>
Should be able to identify and distinguish colors, see clearly at 20 inches or closer and 20 feet or more, observe an area that can be seen up and down or to the left and right while eyes are fixed on a given point, judge distances and spatial relationships, and adjust the eye to bring an object into sharp focus.</li></ul><div></div><div><b><br>
Environmental Conditions</b></div><ul><li>
May be exposed to moderate noise levels (i.e. office equipment, light traffic).</li><li>
May be exposed to moderate to high noise levels (i.e. production equipment, forklifts, heavy traffic).</li><li>
May be exposed to humidity, intense heat and cold, outdoor weather conditions, and fumes and toxic chemicals.</li><li>
May work in areas with mechanical moving parts, above ground with risk of fall, or areas with risk of electrical shock.</li></ul><div></div><div><b><br>
Travel Requirements</b></div><div>
Limited travel may be required.</div><div></div><div><b><br>
About Glanbia</b></div><div>
Glanbia is a better nutrition company with three divisions: Performance Nutrition, Health &amp; Nutrition and Dairy Nutrition. Collectively and with our partners we offer an incredible breadth of expertise in nutrition. We employ a team of 5800 people, work with global food and beverage companies, and sell our award-winning and market-leading brands and ingredients in more than 100 countries worldwide</div><div></div><div><br>
At Glanbia, we celebrate diversity, because we know that our individual strengths make us stronger together. We welcome and encourage interest from a variety of candidates, we will give your application consideration, without regard to race, color, religion, sex, sexual orientation, gender perception or identity, national origin, age, marital status, protected veteran status, or disability status.</div><div></div><div><br>
At Glanbia, our culture celebrates individuality, knowing that together we are more.</div><div></div><div><b><br>
Disclaimer</b></div><div>
Must perform the essential duties and responsibilities with or without reasonable accommodation efficiently and accurately without causing significant safety threat to self or others. The above statements are intended to describe the general nature and level of work being performed by employees assigned to this classification. They are not intended to be construed as an exhaustive list of all responsibilities, duties and/or skills required of all personnel so classified.</div><div></div><div><br>
Compensation for roles at Glanbia varies depending on a wide range of factors including but not limited to the specific office location, role, skill set and level of experience. Glanbia provides a reasonable range of compensation for roles that may be hired in California. This range may not be applicable to other locations. Factors that could be used to determine your actual salary may include your specific skills, years of experience and comparison to current employees already in this role. The annual salary for CA based employees for this role is $75,000 - $85,000 with an annual bonus.</div></div>

Quality Assurance Specialist

McDermott International, Ltd

<div>
 <strong>
  Job Description
  <br/>
  <br/>
 </strong>
 <strong>
  Job Overview:
  <br/>
  <br/>
 </strong>
 The Senior QHSES Assurance Specialist uses best practices and knowledge of internal or external issues to improve the QHSES Assurance discipline within McDermott. They will act as a resource for colleagues with less experience and share their conceptual and practical expertise related to the QHSES Assurance discipline. They solve complex problems and use discipline-specific knowledge to improve their products or services. The Senior QHSES Assurance Specialist impacts a range of customer, operational, project, or service activities with the QHSES Assurance team and other related teams and ensures that they work within the appropriate guidelines and policies. this role is required for Electrical adn Instrumentation scope.
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  Responsibilities
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  Key Tasks and Responsibilities:
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   Support the development and establishment of the new management system
  </li>
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   Partner with Functional Process Subject Matter Experts to drive major Quality Systems initiatives
  </li>
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   Identify and work with Quality Directors to resolve complex issues that have implications beyond the functional area
  </li>
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   QC system attribute for the documents to ensure quality reporting from the system
  </li>
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   Assist Functional Process Subject Matter Experts in the withdrawal of legacy practices from existing systems
  </li>
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   Administer training for new team members
  </li>
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   Participate in the design, implementation, and enforcement of company document templates for the development or revision of all documents
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   Interface with Functional Process Subject Matter Experts and advice on best practices for the creation of documents and organization within the management system
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   Report and status progress as required by the execution plan and requested by Management
  </li>
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   Demonstrate solid and consistent communication within and across functions, with the ability to persuade staff to change their way of working to incorporate quality management methods
  </li>
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   Plan, develop, organize, write, and edit engineering and company procedures and other related documents
  </li>
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   Analyze the documents to maintain the continuity of the style of content
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   Suggest modifications to documents to make them easier to understand
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   Manage updates and revisions to technical literature
  </li>
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   Perform quality check of documents with an emphasis on sentence structure, grammar, and spelling
  </li>
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   Prepare and review procedures and work instructions
  </li>
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   Provide project bids support related to quality upon request
  </li>
  <li>
   Perform audits (internal and external) as per plan monthly &amp; report timely results /reports
  </li>
  <li>
   Oversee the KPI, QI, and Performance Quality process, trend analysis, and initiate ground-level documentation and understanding for benchmarking and lessons learned within the operating units Analyze trends and measured data to assist in setting targets, future planning, and establishing action plans for improvement and effective follow-up to verify compliance
  </li>
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   Lead and perform RCA for quality-related issues
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   <br/>
  </li>
 </ul>
 <strong>
  Qualifications
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 </strong>
 <strong>
  Essential Qualifications and Education:
  <br/>
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 </strong>
 <ul>
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   Bachelor&rsquo;s Degree in a relevant field of study
  </li>
  <li>
   8+ years of relative industry experience related to EPC construction or fabrication
  </li>
  <li>
   Ability to work as a team member as well as act as a team leader
  </li>
  <li>
   Ability to understand and positively respond to organizational demands in a continuously changing business environment
  </li>
  <li>
   Demonstrate strong decision-making skills
  </li>
  <li>
   Strong analytical and organizational skills for evaluating trending data
  </li>
  <li>
   Must have strong interpersonal skills to work with other departments in a tactful and effective manner
  </li>
  <li>
   Communication and presentation skills, both written and spoken
  </li>
  <li>
   Computer literate in Microsoft programs: Word, Visio, PowerPoint, and Excel
  </li>
  <li>
   Strong attention to detail
  </li>
  <li>
   Skilled at prioritization and multi-tasking
  </li>
  <li>
   Able to write in explanatory and procedural styles for multiple audiences
  </li>
  <li>
   Document Management is a plus
  </li>
  <li>
   Competent in dealing with a variety of variables in situations where only limited standardization may exist
  </li>
  <li>
   Possesses a strong understanding of Lean/Continuous Improvement concepts, principles, and practice
  </li>
  <li>
   ISO9001, AS9100, AS9110, or other globally recognized Quality Management Systems Internal Auditor training preferred
  </li>
  <li>
   Translate concepts and information into simplified written and visual instruction or training material. Uses stakeholder feedback to modify and improve solutions
  </li>
  <li>
   Strong ability to communicate at all levels within the organization and the ability to summarize and explain complex technical situations
   <br/>
   <br/>
  </li>
 </ul>
 <strong>
  About Us
  <br/>
  <br/>
 </strong>
 Our ingenuity fuels daily life. Together, we&rsquo;ve forged some of the most trusted partnerships across the energy value chain to make what was once just an idea a reality: laying subsea infrastructure thousands of feet below sea level, installing platforms hundreds of miles from shore, using our expertise to design and build offshore wind infrastructure, and reshaping the onshore landscape to deliver the energy products the world needs safely and sustainably.
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 For more than 100 years, we've been making the impossible possible. Today, we're driving the energy transition with more than 30,000 of the brightest minds across 54 countries.
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</div>


Senior QHSES Assurance Specialist

Eurofins BioPharma Product Testing North America

<div>
 <p>
  <strong>
   Eurofins Scientific is an international life sciences company, providing a unique range of analytical testing services to clients across multiple industries, to make life and our environment safer, healthier and more sustainable. From the food you eat, to the water you drink, to the medicines you rely on, Eurofins laboratories work with the biggest companies in the world to ensure the products they supply are safe, their ingredients are authentic and labelling is accurate.
   <br/>
   <br/>
  </strong>
 </p>
 <p>
  <strong>
   The Eurofins network of companies is the global leader in food, environment, pharmaceutical and cosmetic product testing and in agroscience Contract Research Organization services. It is one of the market leaders in certain testing and laboratory services for genomics, discovery pharmacology, forensics, advanced material sciences and in the support of clinical studies, as well as having an emerging global presence in Contract Development and Manufacturing Organizations. It also has a rapidly developing presence in highly specialized and molecular clinical diagnostic testing and in-vitro diagnostic products.
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   <br/>
  </strong>
 </p>
 <p>
  <strong>
   In over 30 years, Eurofins has grown from one laboratory in Nantes, France to 58,000 staff across a decentralized and entrepreneurial network of 900 laboratories in over 54 countries. Eurofins companies offer a portfolio of over 200,000 analytical methods to evaluate the safety, identity, composition, authenticity, origin, traceability and purity of biological substances and products.
   <br/>
   <br/>
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 </p>
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  <strong>
   2025, Eurofins generated total revenues of EUR &euro; 7.296 billion, and has been among the best performing stocks in Europe over the past 20 years.
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 <strong>
  Job Description
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  Under minimal supervision, the Quality Assurance Specialist II will ensure systems and processes are in a state of compliance with regard to internal, regulatory, and industry standards. He/she will promote a culture of quality for the Company. Candidates in this position will routinely report on the performance of the Quality System to senior leadership. Additionally, candidates will identify CAPAs, NCMRs, Change Controls, Process Improvements, and execute Root Cause Analysis.  Candidates will participate in both internal (annual, for cause, etc.) and external (client, regulatory agencies, accreditation bodies, etc.) audits. Candidates will maintain the Controlled Document System and all associated tasks necessary to keep this system functional, current, and compliant.
  <br/>
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 </p>
 <p>
  <strong>
   Essential Duties/Responsibilities:
   <br/>
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  </strong>
 </p>
 <ul>
  <li>
   Participate in all aspects of Quality Assurance to ensure sterilization activities are performed in compliance with both internal procedures and external cGXP/ISO requirements.
  </li>
  <li>
   Participate in the internal auditing program to ensure the established techniques are followed and understood.
  </li>
 </ul>
 <ul>
  <li>
   Participate in the planning, preparation, and hosting of customer, regulatory, and accreditation audits; respond to audit reports and implement resolution of audit findings; complete Supplier assessment evaluations.
  </li>
 </ul>
 <ul>
  <li>
   Maintain and control site-specific procedures including Standard Operating Procedures, Protocols, Forms, NCMRs, CAPAs, Deviations, Complaints/Inquiries, Change Orders, quality data sheets/records, calibration records, training records and logs.
  </li>
  <li>
   Manage and control the Document System in compliance with the FDA regulations, ISO 13485:2016 guidelines, and company policies.
  </li>
 </ul>
 <ul>
  <li>
   Review Work Order forms.
  </li>
  <li>
   Audit various reports prior to issuance (e.g. validation reports, audit reports, etc.).  Serve as site contact for quality inquiries on reports and related documentation.
  </li>
 </ul>
 <ul>
  <li>
   Create, revise, review, and approve newly written documents and document revisions.
  </li>
  <li>
   Work with Operations Management to maintain the training program and ensure that operations personnel have completed all necessary training requirements.
  </li>
  <li>
   Train site personnel in GXP/ISO procedures, practices, and guidelines.
  </li>
  <li>
   Maintain Customer validation report logs and requalification due dates
  </li>
  <li>
   Initiate and process DCOs, NCMRs and CAPAs and participate in related investigations and document findings with data
  </li>
  <li>
   Assist management in preparing for the Management Review process.
  </li>
 </ul>
 <ul>
  <li>
   Assist management in ensuring all licenses remain current (e.g. ISO, FDA, City, etc.)
  </li>
  <li>
   Collect, track, and analyze quality metrics (OOS, NCMRs, CAPAs, complaints, etc.) and train
   <br/>
   <br/>
   laboratory personnel, as needed to help reduce quality events.
  </li>
  <li>
   Monitor laboratory compliance with respect to lab cleanliness, training records, and other ISO/GMP-related items, as needed to help minimize laboratory errors and audit findings.
  </li>
  <li>
   Assist senior leadership in maintaining the list of approved suppliers and subcontractors.
  </li>
  <li>
   Exist as a backup for other Quality Assurance personnel.
  </li>
  <li>
   Other duties as assigned by departmental management.
   <br/>
   <br/>
  </li>
 </ul>
 <strong>
  Qualifications
  <br/>
  <br/>
 </strong>
 <p>
  <strong>
   Education:
   <br/>
   <br/>
  </strong>
 </p>
 <ul>
  <li>
   <strong>
    Bachelor&rsquo;s degree in chemistry, biological science, or other related life science field.
   </strong>
  </li>
  <li>
   <strong>
    Authorization to work in the United States indefinitely without restriction or sponsorship
   </strong>
  </li>
 </ul>
 <p>
  <strong>
   Experience:
   <br/>
   <br/>
  </strong>
 </p>
 <ul>
  <li>
   1-3 years of laboratory quality assurance experience.
  </li>
  <li>
   Must have experience working in a GMP facility.
  </li>
  <li>
   ISO 13485:2016 accredited lab experience preferred.
  </li>
  <li>
   Moderate understanding of sterilization processes and procedures
  </li>
 </ul>
 <p>
  <strong>
   Capabilities:
   <br/>
   <br/>
  </strong>
 </p>
 <ul>
  <li>
   Must be a detail-oriented, self-initiating individual with strong interpersonal written and oral communication skills.
  </li>
  <li>
   Strong organizational skills, and ability to multitask in a dynamic, fast-paced
   <br/>
   <br/>
   environment.
  </li>
  <li>
   Displays sound judgment and ambition; is quality focused; displays good communication skills; good implementation and follow-up skills.
  </li>
  <li>
   Hands-on experience with CAPA, NCMR, change control, and validation documentation (IQ/OQ/PQ).
  </li>
  <li>
   Strong problem-solving skills, including root cause analysis using formal RCA
   <br/>
   <br/>
   tools such as Ishikawa and 5Ys.
   <br/>
   <br/>
  </li>
 </ul>
 <strong>
  <strong>
   Additional Information
   <br/>
   <br/>
  </strong>
 </strong>
 <p>
  Position is full-time, Monday - Friday, 7:30am - 4:00pm.  Candidates currently living within a commutable distance of San Jose, CA are encouraged to apply.
  <br/>
  <br/>
 </p>
 <p>
  <strong>
   The pay rate of this role is $28.00/hr
   <br/>
   <br/>
  </strong>
 </p>
 <p>
  <strong>
   Eurofins USA BioPharma Services is a Disabled and Veteran Equal Employment Opportunity employer.
   <br/>
   <br/>
  </strong>
 </p>
</div>


Quality Specialist II

Abbott

<div><p>Abbott is a global healthcare leader that helps people live more fully at all stages of life. Our portfolio of life-changing technologies spans the spectrum of healthcare, with leading businesses and products in diagnostics, medical devices, nutritionals and branded generic medicines. Our 115,000 colleagues serve people in more than 160 countries.</p><p><b>
Working at Abbott
</b></p><div><div><p>At Abbott, you can do work that matters, grow, and learn, care for yourself and your family, be your true self, and live a full life. You&rsquo;ll also have access to:</p><ul><li>
Career development with an international company where you can grow the career you dream of.</li><li>
Employees can qualify for free medical coverage in our Health Investment Plan (HIP) PPO medical plan in the next calendar year.</li><li>
An excellent retirement savings plan with a high employer contribution. &middot; Tuition reimbursement, the Freedom 2 Save student debt program, and FreeU education benefit - an affordable and convenient path to getting a bachelor&rsquo;s degree.</li><li>
A company recognized as a great place to work in dozens of countries worldwide and named one of the most admired companies in the world by Fortune.</li><li>
A company that is recognized as one of the best big companies to work for as well as the best place to work for diversity, working mothers, female executives, and scientists.</li></ul><p></p><p><b>
The Opportunity
</b></p><p>Our diagnostic solutions are used in hospitals, laboratories, and clinics around the globe. The crucial information derived from our tests, instruments, and informatics systems is often the first step in patient care decision-making for hundreds of health conditions from heart attacks to blood disorders to infectious diseases and cancers.</p><p></p><p>
Our Core Lab team is looking for a <b>Specialist, Quality Assurance </b>out of our <b>Irving, TX </b>office. They are responsible for administrative and tactical activities that support the effective operation of the Quality Assurance function and overall Quality System. This role within the Operations Quality organization ensures the accurate execution of documentation, system transactions, containment activities, and product review and approval processes, contributing to efficient operations and the delivery of high‑quality products.</p></div><p></p><div><p><b>
Responsibilities
</b></p><ul><li><p>Responsible for implementing and maintaining the effectiveness of the Quality System.</p></li><li><p>
Participate in Quality System processes which may include training, corrective action and preventive action (CAPA) activities, equipment maintenance, product and process planning, quality audits, validation.</p></li><li><p>
Assist in determining quality attributes and requirements. may provide technical assistance.</p></li><li><p>
Utilize quality management techniques to perform investigations and facilitate solutions.</p></li><li><p>
Responsible for completing documentation in a timely manner and in accordance with business standards.</p></li><li><p>
Participate on cross-functional teams.</p></li><li><p>
Other tasks and duties as assigned.</p></li><li><p>
Understand and comply with applicable EHS policies, procedures and guidelines.</p></li><li><p>
Works under the supervision of more experienced staff who review results for overall accuracy, completeness and sound judgment.</p></li><li><p>
Recognizes risks versus the relative gains associated with actions; understands a project's critical success factors and makes recommendations and decisions impacting those factors.</p></li><li><p>
Responsible to meet established objectives and goals.</p></li><li><p>
Drives functional performance to ensure that cross-functional standards and expectations are met.</p></li><li><p>
May assist in the training of personnel as directed by management.</p></li></ul><p></p><p><b>
Education and Experience
</b></p><ul><li><p>Bachelor's Degree OR equivalent combination of education and experience.</p></li><li><p>
Entry level position in which 0-2 years of experience is typical to meet the skills and responsibilities of the position.
</p></li><li><p>Knowledge of FDA Quality System Requirements and other applicable US Code of Federal Regulations for Devices.</p></li><li><p>
Knowledge of ISO 13485 standard.</p></li><li><p>
Knowledge of quality management techniques and application.</p></li><li><p>
Ability to clearly, concisely and accurately convey communications.</p></li><li><p>
Ability to form and develop interpersonal, professional relationships.</p></li><li><p>
Display socially and professionally appropriate behavior.</p></li><li><p>
Ability to work independently and in groups.</p></li><li><p>
Ability to work cross-functionally.</p></li><li><p>
Demonstrated initiative and problem-solving skills.</p></li><li><p>
Critical-thinking skills.</p></li><li><p>
Ability or aptitude to use various types of databases and other computer software.</p></li><li><p>
Strong organizational skills.</p></li><li><p>
Ability to prioritize.</p></li><li><p>
Ability to multitask.</p></li><li><p>
Ability or aptitude to provide solutions and contingency plans through the comprehensive review of alternatives.</p></li><li><p>
Ability to quickly gain knowledge, understanding or skills and is willing to learn.</p></li></ul><p></p><p><b>
Apply Now</b></p><p><b>
Learn more about our health and wellness benefits, which provide the security to help you and your family live full lives:</b> https://abbottbenefits.com/</p><p>
Follow your career aspirations to Abbott for diverse opportunities with a company that can help you build your future and live your best life. Abbott is an Equal Opportunity Employer, committed to employee diversity.</p><p>
Connect with us at abbott.com, on LinkedIn at https://www.linkedin.com/company/abbott-/, and on Facebook at https://www.facebook.com/AbbottCareers.</p></div></div><p><br>
The base pay for this position is $50,700.00 &ndash; $101,300.00. In specific locations, the pay range may vary from the range posted.</p></div>

Specialist, Quality Assurance

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