quality systems specialist

Nestlé USA

<div></div><div><div><b>Factory Food Safety </b><b>Specialist</b></div><p><b>
POSITION SNAPSHOT</b></p><div>
Location: 3rd Industrial City, Jeddah, Kingdom of Saudi Arabia<br>
Company: Nestl&eacute; Saudi Manufacturing<br>
Full-Time Contract
</div><div>Reports to: Factory Quality Manager</div><div>
Work Modality: 100% on-site</div><div></div><p><b><br>
POSITION SUMMARY</b></p><div>
Joining Nestl&eacute; means you are joining the largest Food and Beverage Company in the world. At our very core, we are a human environment - passionate people driven by the purpose of enhancing the quality of life and contributing to a healthier future. A Nestle career empowers you to make an impact locally and globally, as you are provided with the opportunity to make a mark and stand out, if you seek it. With Nestle, you are enabled and encouraged to grow not only as professionals, but also as people.</div><div><br>
</div><div>We are looking for a Food Safety Specialist who will ensure proper operations in specific Food safety areas (e.g. HACCP, Hygiene, pest Control, Microbiological specifications, microbiology food safety, foreign body management, food contact material, non-food items and chemical contaminants). . This role will be essential to ensuring food safety across all production processes, maintaining compliance with regulations, leading audits, and validating and verifying critical controls. We are seeking someone with strong leadership, initiative, and the ability to drive teams in a highly regulated and fast-paced environment.</div><div></div><div><b><i><br>
Focus of this role is to:</i></b></div><div></div><ul><li><b><i><br>
Ensure food safety and compliance at the factory specifically on food safety related issues
</i></b></li><li><b><i>Strive for Zero Defect &amp; no waste in relation with food safety. Use the tracking/monitoring systems as per the Standards to ensure compliance in the lines/factory</i></b></li><li><b><i>
Handle consumer complaints and lead root cause analysis as well as implementation of the corrective actions.
</i></b></li><li><b><i>Ensure deployment of the State of the art solutions for food safety in the production lines</i></b></li><li><b><i>
Responsible for the training and awareness on food safety requirement in the factory</i></b></li><li><b><i>
Support the other department on food safety related issues and coordinate the action plans for mitigating risks</i></b></li><li><b><i>
Ensure compliance with critical controls (CCP, OPRP, PRP).</i></b></li><li><b><i>
Validate and verify critical controls and prerequisites with both internal and external teams.</i></b></li><li><b><i>
Coordinate and lead audits (FSSC 22000, internal, external, and authority inspections).</i></b></li><li><b><i>
Perform Factory checks Gemba on daily basis to ensure hygiene and food safety standards are adhered to by all factory personnel.</i></b></li><li><b><i>
Liaise with external authorities SFDA, Modon and auditors.</i></b></li><li><b><i>
Manage Pathogens Monitoring Plan</i></b></li></ul><div><br>
</div><p><b>A DAY IN THE LIFE &hellip;</b></p><div></div><div><b><br>
Functional Responsibilities</b></div><div></div><ul><li><b><br>
Quality System &amp; Compliance (Food Safety):</b> Deploy the Standards related to Food Safety Operations and Strategies (Hygiene, microbiology, Foreign body and Contaminants)
</li><li><b>Operations Compliance:</b> Ensure the correct operations in the factory aiming for best in class in connection with Food safety practices (Mapping, controls, tracking, etc)</li><li><b>
Root Cause analysis &amp; Continuous improvement:</b> Sustain monitoring and tracking of the food safety related issues. Ensure action plan and proper implementation of the solutions.
</li><li><b>Food Safety awareness in the factory:</b> Ensure high level awareness and up to date awareness on food safety issues, develop anticipative approach on investigation and continuous improvement</li></ul><div></div><p><b><br>
 What will make you successful&hellip;</b></p><br>
<div></div><ul><li>
Academic Experience: University graduate or equivalent (preferred microbiology, chemistry or food science)</li><li>
Good knowledge of Infant formula products and processes (worked before in production lines is a plus)</li><li>
Operational Experience: Demonstrated capability to lead a group, e.g:</li></ul><ul><li>Group leader in a factory: Deputy QA, Quality Systems, Hygienist; or</li><li>QA specialist in a PTC or R&amp;D Centre, NRC, CO-QM</li><li>Management exposure across several functions</li><li>Experience in working with cross-functional teams (delivering results)</li></ul><ul><li>
Arabic and English communication skills at professional level</li><li>
3 + years of prior experience in food safety or quality assurance.</li><li>
Proficiency in Microsoft Office (Word, Excel)</li><li>
Practical Knowledges of SFDA and Modon and Other Regulatory audits</li><li>
FSSC 22000/ISO 22000 Food Safety Lead Auditor Certificate.
</li><li>Must be full availability to work at the Nestl&eacute; Jeddah Factory &ndash; 3rd Industrial City.</li></ul><div></div><p><br>
We are Nestl&eacute;, the largest food and beverage company. We are 308,000 employees strong driven by the purpose of enhancing the quality of life and contributing to a healthier future. Our values are rooted in respect: respect for ourselves, respect for others, respect for diversity and respect for our future. With more than CHF 91.4 billion sales in 2018, we have an expansive presence with 413 factories in more than 85 countries. We believe our people are our most important asset, so we'll offer you a dynamic inclusive international working environment with many opportunities across different businesses, functions and geographies, working with diverse teams and cultures. Want to learn more? Visit us at www.nestle.com.</p></div>

Food Safety Specialist

Cypress HCM

<div>
 This is an exciting opportunity to join a growing company that focuses on precise, early detection of emerging diseases. The Quality Assurance Specialist ensures products, processes, and documentation meet established quality standards and comply with applicable regulatory requirements. This role blends regulatory submissions and strategy with quality system implementation, auditing, and continuous improvement to support product approvals, market access, and patient safety.
 <br/>
 <br/>
 <strong>
  Responsibilities
  <br/>
  <br/>
 </strong>
 <ul>
  <li>
   Develop, implement, and maintain the Quality Management System (QMS).
  </li>
  <li>
   Plan, conduct, and coordinate internal and supplier audits to ensure compliance with regulatory and accreditation standards (e.g., CLIA, CAP).
  </li>
  <li>
   Manage document control, change control, CAPA, nonconformance management, complaint handling, and MDR/Vigilance activities.
  </li>
  <li>
   Coordinate proficiency testing programs and analyze results to identify trends and improvement opportunities.
  </li>
  <li>
   Ensure all required regulatory licenses and accreditations remain current.
  </li>
  <li>
   Maintain quality documentation, SOPs, and laboratory testing procedures.
  </li>
  <li>
   Prepare, analyze, and present quality metrics and reports for management review.
  </li>
  <li>
   Train and onboard new personnel; review training documentation and monitor ongoing competency of testing staff.
  </li>
  <li>
   Maintain working knowledge of laboratory protocols, specimen processing, equipment operation and maintenance, and data analysis.
  </li>
  <li>
   Review and approve product labeling, packaging, promotional materials, and technical documentation for regulatory compliance.
  </li>
  <li>
   Monitor changes in global regulations, standards, and guidance; assess impact and recommend updates to internal processes.
  </li>
  <li>
   Partner with cross-functional teams (R&amp;D, manufacturing, engineering, clinical, marketing) to embed quality and regulatory requirements early in product development.
  </li>
  <li>
   Lead or support management reviews, regulatory and quality training programs, and continuous improvement initiatives.
  </li>
  <li>
   Prepare, submit, and maintain regulatory filings, documentation, and reports.
  </li>
  <li>
   Coordinate with regulatory and accreditation bodies to support product approvals, certifications, and inspections.
  </li>
  <li>
   Ensure compliance with internal health and safety policies; report and address violations as required.
  </li>
  <li>
   Participate as an external auditor on College of American Pathologists (CAP) inspection teams, as required by the CAP accreditation program.
   <br/>
   <br/>
  </li>
 </ul>
 <strong>
  Requirements And Desired Experience
  <br/>
  <br/>
 </strong>
 <ul>
  <li>
   Bachelor's degree (required) in life sciences, biology, chemistry, engineering, pharmacy, or related field; Master's a plus
  </li>
  <li>
   3+ years of laboratory experience, including experience with audits, compliance systems, and regulatory submissions.
  </li>
  <li>
   Strong knowledge of key regulations and standards: FDA QSR (21 CFR Part 820/211), ISO 13485/9001, EU MDR/IVDR, GMP, ICH guidelines, etc.
  </li>
  <li>
   Working knowledge of relevant regulatory frameworks
  </li>
  <li>
   Professional certification is a plus (i.e, Regulatory Affairs Certification &ndash; RAC, ASQ Certified Quality Auditor &ndash; CQA).
  </li>
  <li>
   CLS Generalist or CGMBS license preferred
  </li>
  <li>
   Proven knowledge of quality assurance terminology, software, methods, and tools.
  </li>
  <li>
   Previous experience with Laboratory Information Management Systems is preferred.
  </li>
  <li>
   Proficient in QMS software (i.e. MediaLab, TrackWise, MasterControl or similar)
  </li>
  <li>
   Strong analytical, problem-solving, and decision-making skills.
  </li>
  <li>
   Experience in compliance and/or regulatory and knowledge of laboratory standards and regulations
  </li>
  <li>
   Experience with Microsoft Office Suite; Word, Outlook, Excel
  </li>
  <li>
   Excellent written and verbal communication skills for agency interactions, technical writing, and cross-functional collaboration.
  </li>
  <li>
   Able to effectively present information and respond to questions from various stakeholders
   <br/>
   <br/>
  </li>
 </ul>
 <strong>
  Compensation (DOE):
 </strong>
 $80,000 - $95,000 annual salary
 <br/>
 <br/>
</div>


Quality Assurance Specialist

NAKILAT

<div>
 <p>
  <strong>
   Job Title: HSSEQ System Specialist
  </strong>
 </p>
 <p>
  <br/>
 </p>
 <p>
  <br/>
 </p>
 <p>
  <strong>
   Job Summary and Purpose
  </strong>
 </p>
 <p>
  Ensure the Company&rsquo;s Safety Management System is maintained up to date, to ensure safe operations of the vessels, and that ships are kept fully informed, and the system is updated in a timely manner.
 </p>
 <p>
  As well as monitor and review NSQL Safety Management System, SMS update System, Omni safe and Desktop to ensure that systems are updated and remain aligned.
 </p>
 <p>
  <br/>
 </p>
 <p>
  <strong>
   Accountabilities
  </strong>
 </p>
 <p>
  <br/>
 </p>
 <p>
  <strong>
   <u>
    Systems Management:
   </u>
  </strong>
 </p>
 <p>
  <br/>
 </p>
 <ul>
  <li>
   Ensure that the NSQL Cloud based Safety Management System (SMS) is kept up to date and the vessels are kept up to date with the latest changes.
  </li>
  <li>
   Handle the &ldquo;Management of Change&rdquo; Process for NSQL SMS.
  </li>
  <li>
   Develop the company document Management System, which includes revision control, change requests and document formatting.
  </li>
 </ul>
 <p>
  <br/>
 </p>
 <p>
  <strong>
   <u>
    Audits and Compliances:
   </u>
  </strong>
 </p>
 <p>
  <br/>
 </p>
 <ul>
  <li>
   Administer the Fleet Drug and Alcohol testing program, to ensure compliance with Company Policy.
  </li>
  <li>
   Handle the scheduling and the timely organizing of ship&rsquo;s external and internal ISM/ISPS/MLC audits within relevant deadlines.
  </li>
  <li>
   Support alternate company Security Officers in engaging Armed Guards on board NSQL vessels, to ensure compliance with Company Policy.
  </li>
  <li>
   Assist the DDPA (Deputy Designated Person Ashore) in providing trend analysis and root cause analysis on all reported non-conformities, audits and inspections.
  </li>
  <li>
   Prepare materials related to the Technical Operational Review, which includes statistics of fleet performance; where data is usually gathered from different bespoke programs (such as Omni safe).
  </li>
 </ul>
 <p>
  <br/>
 </p>
 <p>
  <strong>
   <u>
    Records/Document Management:
   </u>
  </strong>
 </p>
 <p>
  <br/>
 </p>
 <ul>
  <li>
   Maintain the HSSEQ section records, and monitor the status of the Mandatory Quality /Safety/ Security Training programs.
  </li>
  <li>
   Ensure accurate records keeping of all security related documentation in accordance with the ISPS code.
  </li>
  <li>
   Monitor all HSSEQ related contracts and ensure their validity.
  </li>
 </ul>
 <p>
  <br/>
 </p>
 <p>
  <strong>
   <u>
    Quality, Health, Safety, &amp; Environment (QHSE):
   </u>
  </strong>
 </p>
 <p>
  <br/>
 </p>
 <ul>
  <li>
   Adhere to all relevant QHSE policies, procedures, instructions and controls so that NAKILAT provides a safe, world class, secure and environmentally responsible service to customers, the public and its own people.
  </li>
 </ul>
 <p>
  <br/>
 </p>
 <p>
  <strong>
   <u>
    Policies, Systems, Processes &amp; Procedures:
   </u>
  </strong>
 </p>
 <ul>
  <li>
   Follow all relevant divisional policies, processes and procedures so that work is carried out in a controlled and consistent manner.
  </li>
 </ul>
 <p>
  <br/>
 </p>
 <p>
  <strong>
   <u>
    Others:
   </u>
  </strong>
 </p>
 <ul>
  <li>
   Maintains and updates the Fleet HSSEQ section&rsquo;s site at the company portal.
  </li>
  <li>
   Assist in the registration of the existing fleet vessels.
  </li>
  <li>
   Handle the issuance of all Fleet and Flag State Circular, and ensure that they are acknowledged in company system &ldquo;Desktop&rdquo; by relevant parties as required by the SMS.
  </li>
  <li>
   Supports Company Designated Person and Security Officer in all matters related to Safety and Security.
  </li>
  <li>
   Carry out any other duties as directed by the immediate supervisor.
  </li>
 </ul>
 <p>
  <br/>
 </p>
 <p>
  <strong>
   Qualifications, Experience and Job Skills
  </strong>
 </p>
 <p>
  <br/>
 </p>
 <p>
  <strong>
   <u>
    Qualifications:
   </u>
  </strong>
 </p>
 <ul>
  <li>
   Bachelor&rsquo;s degree / Diploma in Engineering, Science, Occupational Health and Safety or any other related filed.
  </li>
 </ul>
 <p>
  <br/>
 </p>
 <p>
  <strong>
   <u>
    Experience:
   </u>
  </strong>
 </p>
 <ul>
  <li>
   3 years of experience working in Marine industry, in fields related to Safety, Health, Environment and Quality Management.
  </li>
  <li>
   Solid knowledge of ISO/OHSAS Quality and Safety systems.
  </li>
  <li>
   Solid knowledge of administering quality management and change control management.
  </li>
  <li>
   Solid knowledge of document control systems
  </li>
  <li>
   Solid experience of developing and writing Company policy and procedures.
  </li>
 </ul>
 <p>
  <br/>
 </p>
 <p>
  <strong>
   <u>
    Job Specific Skills:
   </u>
  </strong>
 </p>
 <ul>
  <li>
   Excellent English language skills &ndash; written and oral.
  </li>
  <li>
   Good communications skills both oral and written
  </li>
  <li>
   Ability to identify problems and provide effective solutions.
  </li>
  <li>
   Service and quality oriented.
  </li>
  <li>
   Excellent knowledge of various computer programs (Excel, Word, PowerPoint, Visio, Adobe Acrobat etc.)
  </li>
 </ul>
</div>


HSSEQ System Specialist

McDermott

<div><p><b>Job Overview:
</b></p><p>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.
<br>
<br>
This role is required to lead a team of Project Procurement QA Engineers.</p></div>
<br><div><div>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.
<br>
<br>
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.</div></div>
<br><div><p><b>Essential Qualifications and Education:
</b></p><ul><li>Support the development and establishment of the new management system
</li><li>Partner with Functional Process Subject Matter Experts to drive major Quality Systems initiatives
</li><li>Identify and work with Quality Directors to resolve complex issues that have implications beyond the functional area
</li><li>QC system attribute for the documents to ensure quality reporting from the system
</li><li>Assist Functional Process Subject Matter Experts in the withdrawal of legacy practices from existing systems
</li><li>Administer training for new team members
</li><li>Participate in the design, implementation, and enforcement of company document templates for the development or revision of all documents
</li><li>Interface with Functional Process Subject Matter Experts and advice on best practices for the creation of documents and organization within the management system
</li><li>Report and status progress as required by the execution plan and requested by Management
</li><li>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><li>Plan, develop, organize, write, and edit engineering and company procedures and other related documents
</li><li>Analyze the documents to maintain the continuity of the style of content
</li><li>Suggest modifications to documents to make them easier to understand
</li><li>Manage updates and revisions to technical literature
</li><li>Perform quality check of documents with an emphasis on sentence structure, grammar, and spelling
</li><li>Prepare and review procedures and work instructions
</li><li>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><li>Lead and perform RCA for quality-related issues</li></ul></div>
<br><div><p><b>Key Tasks and Responsibilities:
</b></p><ul><li>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
</li></ul><p>#LI-JG2</p></div>

Senior QHSES Assurance Specialist

Eurofins

<div><b>Company Description</b><p><b><br>
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.</b></p><p><b>
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.</b></p><p><b>
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.</b></p><p><b>
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.</b></p><p></p><b><br>
Job Description</b><p><br>
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.</p><p><b>
Essential Duties/Responsibilities:</b></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><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>
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.</li></ul><br>
<b>
Qualifications</b><p><b><br>
Education:</b></p><ul><li><b>
Bachelor&rsquo;s degree in chemistry, biological science, or other related life science field.</b></li><li><b>
Authorization to work in the United States indefinitely without restriction or sponsorship</b></li></ul><p><b>
Experience:</b></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><b>
Capabilities:</b></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>
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>
tools such as Ishikawa and 5Ys.</li></ul><br>
<b>
Additional Information</b><p><br>
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.</p><p><b>
The pay rate of this role is $28.00/hr</b></p><div></div><p><b>
Eurofins USA BioPharma Services is a Disabled and Veteran Equal Employment Opportunity employer.</b></p></div>

Quality Specialist II

CooperCompanies

<div><div>CooperSurgical is a leading fertility and women&rsquo;s healthcare company dedicated to putting time on the side of women, babies, and families at the healthcare moments that matter most in life. As a division of CooperCompanies, we're driven by a unified purpose to enable patients to experience life's beautiful moments. Guided by our shared values &ndash; dedicated, innovative, friendly, partners, and do the right thing &ndash; our offerings support patients throughout their lifetimes, from contraception to fertility and birth solutions, to women&rsquo;s and family care, and beyond. We currently offer over 600 clinically relevant medical devices to healthcare providers, including testing and treatment options, as well as an innovative suite of assisted reproductive technology and genomic testing solutions. Learn more at www.coopersurgical.com.</div></div><p></p>
<br>The Life Science Quality Assurance Specialist I support the Quality Assurance Team. The role will help with contribute to Quality Assurance processes within the electronic Document Management System (eDMS). The individual will have the opportunity to collaborate within the Quality team and greater operations team to help with minor nonconformities, troubleshooting, reconciliation, and investigations.
<br><div><ul><li><div>Understands and applies comprehensive knowledge of quality principles and maintains current understanding of regulations.
</div></li><li><div>Familiarity or experience with the following is strongly preferred: Basic statistics, review/approval of documentation; risk tools, technical writing, and writing/reviewing/approving investigations.
</div></li><li><div>The candidate should have strong written and verbal communication skills to foster cross-functional collaboration and partnerships, lead by positive influence, maintain a high level of integrity, and possess a strong continuous improvement mindset.
</div></li></ul><div>Computer Skills:
</div><ul><li><div>Knowledge of Master Control, or similar eQMS a plus
</div></li><li><div>Demonstrated experience and proficiency in Microsoft Office applications, Word, Excel and PowerPoint.
</div></li></ul><div>Adaptability
</div><ul><li><div>Responds effectively to changing constraints.
</div></li><li><div>Good interpersonal skills and ability to work effectively and efficiently in a team environment to accomplish goals.
</div></li><li><div>Understands the drivers of change and anticipates the implications of changing political and practical circumstances
</div></li><li><div>Applies a preventative instead of corrective approach
</div></li><li><div>Attention to Detail
</div></li><li><div>Checks information, picks up inconsistencies and mistakes and can make detailed comparisons between similar sources
</div><ul><li><div>Positive work attitude that supports teamwork and continuous improvement.
</div></li></ul></li></ul><div>Decision Making
</div><ul><li><div>Makes pragmatic decisions based on range of factors
</div><ul><li><div>Able to make decisions quickly where necessary, based on incomplete information
</div></li><li><div>Demonstrates logic to back up decisions
</div></li><li><div>Excellent critical analytical skills &ndash; ability to find root cause of why and issue occurred.
</div></li></ul></li></ul><div>Initiative
</div><ul><li><div>Identifies ways to improve processes/situations
</div><ul><li><div>Takes responsibility for improvements or solving problems.
</div><ul><li><div>Must display eagerness to learn and continuously improve.
</div></li><li><div>Sets own standards above prevailing standards, shows dissatisfaction with substandard or inefficient activities Interpersonal Skills
</div></li><li><div>Socially capable - interacts confidently, reads the situation
</div></li><li><div>Empathetic and can evaluate likely reactions
</div></li><li><div>Collaborative approach
</div></li></ul></li></ul></li></ul><div>Results Oriented
</div><ul><li><div>Ability to focus on important issues only. Risk based approach
</div><ul><li><div>Regularly refocuses on results
</div></li><li><div>Demonstrates a drive to exceed performance targets
</div></li></ul></li></ul><div>Task Management
</div><ul><li><div>Ability to handle multiple tasks and competing priorities concurrently and in a timely fashion
</div><ul><li><div>Prioritizes and monitors tasks progress
</div></li><li><div>Makes realistic estimates of time and resource requirements<br>
</div></li></ul></li></ul><div></div><div><b>Work Environment:
</b></div><ul><li><div>The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
</div></li><li><div>While performing the duties of this job, the employee is regularly required to sit and talk or hear. The employee is occasionally required to stand; walk; use hands to finger, handle, or feel; and reach with hands and arms. Specific vision abilities required by this job include close vision.<br>
</div></li></ul><div></div><div><b>Experience/ Education:
</b></div><ul><li><div>Bachelor&rsquo;s degree (BA) from four-year college or university or Associates degree (A.A.) with one to three years related experience and/or training.
</div></li><li><div>OR two to three years related experience and/or training; or equivalent combination of education and experience.
</div></li></ul><div>As an employee of CooperSurgical, you'll receive an outstanding total compensation plan. As we believe your compensation goes beyond your paycheck, we offer a great compensation package, medical coverage, 401(k), parental leave, fertility benefits, paid time off for vacation, personal, sick and holidays, and multiple other perks and benefits. Please visit us at www.coopersurgical.com to learn more about CooperSurgical and the benefits of becoming a member of our team.
</div><p>To all agencies: Please, no phone calls or emails to any employee of CooperSurgical about this opening. All resumes submitted by search firms/employment agencies to any employee at CooperSurgical via-email, the internet or in any form and/or method will be deemed the sole property of CooperSurgical, unless such search firms/employment agencies were engaged by CooperSurgical for this position and a valid agreement with CooperSurgical is in place. In the event a candidate who was submitted outside of the CooperSurgical agency engagement process is hired, no fee or payment of any kind will be paid.
</p><p>We are committed to equal employment opportunity regardless of race, color, ancestry, religion, sex, national origin, sexual orientation, age, citizenship, marital status, disability, gender, gender identity or expression, or veteran status. We are proud to be an equal opportunity workplace. If you are interested in applying and require special assistance or accommodations due to a disability, please contact us at talent.acquisition@coopersurgical.com</p></div>
<br><div><ul><li>Contribute to the Quality Systems under the direction of Quality Assurance Manager/ Supervisor
</li><li>Responsible for the implementation and adherence to instructions in the routine review of laboratory records in accordance with site standard operating procedures, good documentation practices (GDP) and Quality Management Systems (QMS)
</li><li>Maintain understanding and responsible for adherence to company standards, guidelines and QMS processes to support and help stakeholders with applicable instructions.
</li><li>Perform documentation review and audit in accordance to Good Documentation Practice (GDP).
</li><li>Perform data analysis, review, tracking, trending, creating graphs and reports as required for each Quality Management System modules monitoring timeliness and effectiveness.
</li><li>Manage Record Management, electronic Document Management System and update documentation in accordance to templates and guidelines.
</li><li>Communicate and collaborates with appropriate staff and Project Teams regarding Document revision staff. Aid in writing, revising procedures and formatting.
</li><li>Perform compliance review on executed records for completeness of all required testing and documents for various processes.
</li><li>Lead Minor Non-conformance investigations using root cause analysis.
</li><li>Uses existing procedures to solve routine or standard problems.
</li><li>Basic conceptual knowledge and practices associated with Document Review
</li><li>Recognizes and resolves errors in records and resolves them in a timely manner.
</li><li>Contribute to basic improvement projects.
</li><li>Work cooperatively in a team environment to maintain cross functional, and cross site processes and procedural consistency for quality systems records.
</li><li>Perform other Quality Assurance Duties as required.
</li></ul><div><b>Travel:
</b></div><p> Hybrid (1-3 days a week onsite)
</p><p> Remote</p></div>

Quality Assurance Specialist I

Ubertal Inc.

<div>
 <strong>
  Job Title: Quality Control Technician (Quality Engineer Contract)
  <br/>
  <br/>
 </strong>
 <strong>
  Location:
 </strong>
 100% Remote (Preferred Eastern or Central Time Zones)
 <br/>
 <br/>
 <strong>
  Duration:
 </strong>
 12 Months
 <br/>
 <br/>
 <strong>
  Schedule:
 </strong>
 Full-Time, 40 Hours/Week | Standard Business Hours
 <br/>
 <br/>
 <strong>
  Conversion:
 </strong>
 No FTE conversion available
 <br/>
 <br/>
 <strong>
  Interview Process:
 </strong>
 1 Round
 <br/>
 <br/>
 We are seeking an experienced
 <strong>
  Quality Control Technician
 </strong>
 with strong validation and quality systems expertise to support documentation, statistical quality control, and regulatory compliance initiatives in a highly regulated pharmaceutical or manufacturing environment.
 <br/>
 <br/>
 This role focuses on validation documentation, quality analysis, regulatory compliance, and cross-functional collaboration to ensure systems, products, and processes meet defined reliability and regulatory standards.
 <br/>
 <br/>
 <strong>
  Key Responsibilities
  <br/>
  <br/>
 </strong>
 <ul>
  <li>
   Write, review, approve, and execute validation documentation and technical reports for systems, products, and processes
  </li>
  <li>
   Prepare validation protocols, test equipment, and evaluate validation data
  </li>
  <li>
   Conduct statistical quality control analysis of testing results and process anomalies
  </li>
  <li>
   Prepare reports summarizing study results and conformance to acceptance criteria
  </li>
  <li>
   Support development and maintenance of validation programs and Standard Operating Procedures (SOPs)
  </li>
  <li>
   Verify calibration, maintenance, and repair of instruments supporting Quality Systems validation
  </li>
  <li>
   Participate in FMEA, RCA, and CAPA development activities
  </li>
  <li>
   Ensure corrective and preventive measures meet reliability and compliance standards
  </li>
  <li>
   Maintain working knowledge of FDA, CLIA, cGMP, Medical Device Directives, and other applicable regulatory standards
  </li>
  <li>
   Support procedural document management and regulatory audit readiness
  </li>
  <li>
   Communicate cross-functionally regarding validation studies and project deliverables
   <br/>
   <br/>
  </li>
 </ul>
 <strong>
  Required Qualifications
  <br/>
  <br/>
 </strong>
 <ul>
  <li>
   Bachelor's degree in Science, Engineering, or related field (or equivalent combination of education and relevant experience)
  </li>
  <li>
   Minimum 3 years of quality/validation experience in pharmaceutical manufacturing or a highly regulated industry
  </li>
  <li>
   Strong working knowledge of cGMP principles and regulatory compliance requirements
  </li>
  <li>
   Experience writing and approving validation and technical documentation
  </li>
  <li>
   Experience participating in FMEA, RCA, and CAPA processes
  </li>
  <li>
   Strong analytical, critical thinking, and problem-solving skills
  </li>
  <li>
   Project management skills with ability to manage multiple priorities and tight deadlines
  </li>
  <li>
   Proficiency in Microsoft Office, statistical tools, and electronic quality systems
  </li>
  <li>
   Strong written, verbal, and interpersonal communication skills
  </li>
  <li>
   Ability to maintain confidentiality and demonstrate professional judgment
   <br/>
   <br/>
  </li>
 </ul>
 <strong>
  Preferred Qualifications
  <br/>
  <br/>
 </strong>
 <ul>
  <li>
   ASQ Certification
  </li>
  <li>
   Experience in medical device or regulated laboratory environments
   <br/>
   <br/>
  </li>
 </ul>
 This remote contract opportunity is ideal for a quality professional with deep validation experience, strong regulatory knowledge, and the ability to drive compliance and quality excellence within a regulated pharmaceutical or manufacturing environment.
</div>


Quality Control Technician (Quality Engineer)

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