quality control specialist

Strategic Management Solutions, LLC

<div><div><div><b><i>SMSI</i></b><i> provides expert management consulting, program and project management, and technical consulting services to government and private sector clients. </i><b><i>SMSI</i></b><i> has grown and evolved by building an outstanding reputation for client-focused performance and for delivering results that enable clients to meet commitments and milestones.</i>
</div><div><i>SMSI is an Equal Employment Opportunity employer, all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or status as a protected veteran.</i></div>
</div>
<div></div><div><b>Job Summary:</b></div>
<div>The Quality Control Specialist supports multiple supplier development initiatives and ongoing supplier performance management by performing quality control inspections, validating materials and components, and assisting with supplier performance monitoring. This role ensures that products received from suppliers meet specifications and quality standards, while collaborating with internal teams and suppliers to reduce risk, improve quality, and optimize total cost of ownership. This position is vital for maintaining the integrity of the supply chain and ensuring that end products meet the high standards expected by customers and stakeholders. By leveraging technical expertise, a Quality Control Specialist plays a key role in supply chain management and continuous improvement processes.</div>
<div></div><div><b>Responsibilities &amp; Duties:</b></div>
<ul><li>Support Sourcing Specialists and Supplier Quality Engineers/Quality Assurance Engineers with supplier qualification and approval processes.</li>
<li>Plan and perform visual, dimensional, and functional inspections on materials and components, either in-process or out-going at supplier site, or in-coming at client, per established sampling plans.</li>
<li>Observe supplier-conducted inspection processes as needed.</li>
<li>Document inspection results accurately in QMS or ERP systems per Document Control and Records Management procedures.</li>
<li>Observe first article inspections First Article Inspection <i>(FAI) </i>and Production Part Approval Process (PPAP) verification for new supplier parts.</li>
<li>Support supplier corrective actions <i>(SCARs)</i> by providing inspection data and defect analysis.</li>
<li>Communicate nonconformance findings to suppliers and internal teams promptly.</li>
<li>Maintain inspection records, certificates of compliance, and traceability documentation.</li>
<li>Prepare daily/weekly reports on incoming quality performance and defect trends.</li>
<li>Ensure proper labeling and segregation of accepted and rejected materials.</li>
<li>Work closely with Procurement, Engineering, and Quality Engineers to resolve supplier-related issues.</li>
<li>Support audits and supplier visits by providing inspection data and observations.</li>
<li>Assist in training new team members on inspection techniques and quality standards.</li>
<li>Identify recurring defects and escalate to Quality Engineers for root cause analysis.</li>
<li>Suggest improvements to inspection processes and supplier quality practices.</li>
<li>Other duties and responsibilities as required in support of client business objectives.</li>
</ul>
<div></div><div><b>Required Skills/ Abilities:
</b></div><ul><li>Associate degree in Engineering or Industrial Technology; or comparable vocational training in quality or manufacturing or relevant experience in lieu of degree.</li>
<li>Minimum of 3 years of quality control/ supplier quality representative experience in manufacturing/fabrication environments.</li>
<li>Must currently possess or be able to obtain / maintain an active level Q security clearance.</li>
<li>Experience using precision measurement tools to verify compliance with drawings and specifications.</li>
<li>Accuracy &amp; Detail Orientation; ensures precise measurements and documentation.</li>
<li>Strong analytical and problem-solving skills; identify defects and support resolution.</li>
<li>Excellent communication and interpersonal abilities; ensure clear reporting of inspection results and issues.</li>
<li>Ability to work independently and as part of a team.</li>
<li>Excellent organizational and time management skills.</li>
<li>Proficient in Microsoft Office and quality management software.</li>
</ul><div><b>Educational Requirements:
</b></div><ul><li>Bachelor&rsquo;s degree in an Engineering discipline.</li>
<li>ASQ Certified Quality Technician (CQT) or equivalent.</li>
<li>Experience with quality management systems and standards <i>(e.g., ISO 9001, IATF 16949, AS9100)</i>, NQA-1.</li>
<li>Exposure to (PPAP), (FAI), and supplier quality processes.</li>
</ul><div><b>Required QC Inspection Credentials:</b></div>
<ul><li>Candidates must be certified in three or more of the following Nondestructive Testing <i>(NDT)</i> methods, either by a previous employer or through a national certification agency:</li>
</ul><ul><li>Receiving Inspection</li>
<li>Dimensional Inspection</li>
<li>Mechanical Inspection</li>
<li>Visual Weld Inspection <i>(AWS CWI preferred)</i></li>
<li>Electrical Inspection</li>
<li>Civil Inspection</li>
<li>Leak Testing <i>(Helium Leak Testing preferred)</i></li>
<li>Liquid Penetrant Inspection</li>
<li>Magnetic Particle Inspection</li>
<li>Radiographic Inspection</li></ul></div>

Quality Control Specialist

Rochester Regional Health

<div><p><b>Job Title:</b> Clinical Trials Quality Control Specialist</p><p><b>
Department:</b><b> </b>Specimen Processing</p><p><b>
Location:</b><b> </b>Onsite, Rochester, NY</p><p><b>
Hours Per Week:</b><b> </b>40</p><p><b>
Schedule:</b><b> </b>Days; Monday - Friday</p><p></p><p><b>
SUMMARY</b></p><p>
The Quality Control Specialist is responsible for supporting and maintaining quality control standards for Clinical Trials Specimen Management (CTSM) and the Clinical Trials Laboratory. This role works collaboratively with the leadership team to help ensure consistent quality, compliance, and adherence to best practices within the laboratory.</p><p></p><p><b>
RESPONSIBILITIES</b></p><ul><li>
In coordination with leadership, maintains current knowledge of all applicable regulations, requirements, and standards related to quality control processes.</li><li>
Performs all work in accordance with requirements of regulatory agencies such as CAP, NYSDOH, CLIA, OSHA, ISO and ISBER.</li><li>
Participates in quality control investigations, root cause analysis, corrective/preventative actions, and process improvements.</li><li>
Works with leaders to develop and maintain quality dashboards, quality monitors, regulatory (CAP, NYSDOH) related tasks, key performance indicators and compliance.</li><li>
Performs routine quality control review of equipment validation and qualifications to ensure compliance.</li><li>
Performs QC for shipping, storage and routine samples and documents at a percentage determined by management.</li><li>
Participates in regulatory inspections and client audits by gathering required documentation and providing it to Quality Assurance for internal and external audits.</li><li>
Provides input to appropriate corrective and preventive actions of audit/inspection findings within allotted due date.</li><li>
Performs a routine check of employee training binders and continuing education to ensure they are maintained by team members.</li><li>
Reviews employee competencies to ensure completion of annual and semi-annual competency assessments of all applicable employees.</li><li>
Reviews Best practices and recommends and implements process improvements to streamline operations between the lab/CTSM and other departments.</li><li>
Leads and supports leadership with process rollout and staff (re)trainings</li><li>
Supports leadership by ensuring the development and updating of standard operating procedures, ensuring quality and regulatory compliance are present in the appropriate time frames.</li><li>
Promotes a culture of audit readiness</li><li>
Performs other duties as assigned</li></ul><p></p><p><b>
REQUIRED QUALIFICATIONS</b></p><ul><li>
Associates Degree in science</li></ul><p></p><p><b>
PREFERRED QUALIFICATIONS</b></p><ul><li>
Bachelor&rsquo;s degree in science</li><li>
Good oral and written communication skills</li><li>
Good organization skills</li><li>
Good ability to work independently and in a team setting</li><li>
4-6 years of experience in a Quality role within a clinical laboratory/ medical technology setting</li><li>
High school diploma or equivalent required</li></ul><p></p><p><b>
EDUCATION:</b></p><p></p><p><b>
LICENSES / </b><b>CERTIFICATIONS:</b></p><p></p><p><b>
PHYSICAL REQUIREMENTS:</b></p>
M - Medium Work - Exerting 20 to 50 pounds of force occasionally, and/or 10 to 25 pounds of force frequently, and/or greater than negligible up to 10 pounds of force constantly to move objects; Requires frequent walking, standing or squatting.<p></p><p><b>
For disease specific care programs refer to the program specific requirements of the department for further specifications on experience and educational expectations, including continuing education requirements.</b><b>
</b></p><p></p><p><b>Any physical requirements reported by a prospective employee and/or employee&rsquo;s physician or delegate will be considered for accommodations.
</b></p><p></p><p><b>PAY RANGE:</b></p>
$60,500.00 - $75,000.00<p></p><div><div><div><div><div><div><div><p><b>
CITY:</b></p></div></div></div></div></div></div></div>
Rochester<p></p><div><div><div><div><div><div><div><p><b>
POSTAL CODE:</b></p></div></div></div></div></div></div></div>
14624<p></p><p><b><i>
The listed base pay range is a good faith representation of current potential base pay for a successful full time applicant. It may be modified in the future and eligible for additional pay components. Pay is determined by factors including experience, relevant qualifications, specialty, internal equity, location, and contracts.</i></b></p><p></p><p><b>
Rochester Regional Health is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, creed, religion, sex (including pregnancy, childbirth, and related medical conditions), sexual orientation, gender identity or expression, national origin, age, disability, predisposing genetic characteristics, marital or familial status, military or veteran status, citizenship or immigration status, or any other characteristic protected by federal, state, or local law.</b></p></div>

Clinical Trials Quality Control Specialist

Fresh Catch USA

<p>Objective of the Job Role</p><p>The Quality Control Specialist is responsible for ensuring the highest standards of seafood safety, freshness,and documentation at our production facility. This role acts as the primary gatekeeper for product integrity,managing detailed inspections of high-value species including Tuna, Salmon, and Chilean Seabass. Thespecialist serves as the critical communication link between the local dock operations and management.</p><p>Key Responsibilities</p><p>Product Grading &amp; Inspection</p><ul><li>Tuna Grading: Perform detailed grading of each tuna board per shipment; capture and transmit high-quality photos of each board to management for verification.</li><li>Freshness Audits: Conduct rigorous quality checks on all incoming products, with a focus on delayed shipments. Inspect and document:</li><li>Internal and external temperatures.</li><li>Gills (color/mucus), eyes (clarity), texture (firmness), and overall color.</li><li>Inbound/Outbound Oversight: Audit and verify inspection forms completed by dock personnel; confirm data accuracy before signing and dating for final approval.</li></ul><p>Documentation &amp; Reporting</p><ul><li>Visual Evidence: Capture and organize extensive visual documentation (100+ photos/videos daily) highlighting poor quality or discrepancies in Salmon, Tuna, and Chilean Seabass.</li><li>Inventory Status Tracking: Maintain precise logs regarding product disposition, specifically noting if items were re-used, dumped, or remained at a customer site (not picked up).</li><li>Compliance: Ensure all physical product weights perfectly align with the accompanying pack lists.</li></ul><p>Credit Processing &amp; Global Coordination</p><ul><li>Claims Management: Oversee the end-to-end customer credit request process. Gather all required evidence, including packing lists, return forms, and photographic proof of loss/damage.</li><li>International Liaison: Compile and submit all necessary documentation to the Sri Lanka headquarters for final credit approval and processing.</li><li>Reporting: Provide real-time &quot;Go/No-Go&quot; status reports regarding the viability of delayed products.</li></ul><p>Logistics &amp; Returns</p><ul><li>FedEx Management: Coordinate and execute FedEx drops for urgent customer orders or product returns.</li><li>Inventory Control: Confirm that all inbound and outbound seafood meets both company and regulatory safety standards.</li></ul><p>Qualifications and skills required</p><ul><li>Experience: Minimum of 1&ndash;3 years in quality control, preferably within the seafood or perishable food industry.</li><li>Technical Skills: Proficiency in digital photography and mobile communication apps for high- volume data/photo sharing.</li><li>Detail Oriented: Exceptional ability to spot subtle color, texture, and anatomical changes in various fish species.</li><li>Communication: Strong written and verbal skills.</li><li>Physical Requirements: Ability to work in cold/refrigerated environments (32&deg;F&ndash;40&deg;F) and stand for extended periods on a production dock.</li></ul><p>Preferred Skills</p><ul><li>Knowledge of HACCP (Hazard Analysis Critical Control Point) guidelines.</li><li>HACCP Certification</li><li>Familiarity with Tuna grading standards (e.g., #1, #2+, #2).</li></ul><p>Fresh Catch is an Equal Opportunity Employer. We do not discriminate on the basis of race, color, religion, sex (including pregnancy and gender identity), national origin, political affiliation, sexual orientation, marital status, disability, genetic information, age, membership in an employee organization, retaliation, parental status, military service, or other non-merit factor.</p><p>Pay: From $25.00 per hour</p><p>Benefits:</p><ul><li>401(k)</li></ul><p>Work Location: In person</p>

Quality Control Specialist- Seafood Production

Vertex Pharmaceuticals

<div>Job Description:
<div>
The Vertex Cell and Gene Therapy (VCGT) Type 1 Diabetes (T1D) Quality Control (QC) team is responsible for the testing of samples and associated workflows within our stem-cell based T1D program. VCGT T1D QC carries out all activities under Good Manufacturing Practices (GMP) guidelines.</div><div></div><div><br>
The Quality Control Specialist is responsible for supporting a variety of analytical functions that occur in the Quality Control (QC) department supporting validation, testing and reporting of in-process, release and stability samples. This role also helps ensure activities occur in an efficient and cGMP compliant manner while fostering the Vertex vision and values.</div><div></div><div><b><br>
Shift: Sunday - Wednesday 12:30pm-11:00pm</b></div><div></div><div><b><br>
Key Responsibilities:</b></div><ul><li>
Typical test methods performed include flow cytometry, qPCR (MycoTOOL), ELISA, cell counts, sterility (BACT), Gram stain and endotoxin (LAL) testing.</li><li>
Performs technical reviews of raw data.</li><li>
Records test results and maintains raw data and accurate laboratory records.</li><li>
Performs general lab and equipment maintenance duties.</li><li>
Performs other duties as assigned.</li><li>
Weekend shift work: Typical workweek is a 4 day week, 10 hours a day, Sunday to Wednesday 12:30 PM &ndash; 11:00 PM.</li></ul><div></div><div><b><br>
Knowledge and Skills:</b></div><ul><li>
Performs tasks with strict adherence to cGMP and cGDP principles.</li><li>
Has an understanding of basic laboratory equipment and practices.</li><li>
Is proficient in the use of spreadsheets and word processing software.</li><li>
Is dependable and able to work well within a team.</li><li>
Is interested in learning new things. Open to change.</li><li>
Is optimistic and displays a positive attitude even during periods of adversity.</li><li>
Shows initiative; acts independently with management approval.</li><li>
Possesses a high attention to detail.</li></ul><div><br>
</div><div><b>Requirements:</b></div><ul><li>
A minimum of a Bachelor's degree in Sciences is required.</li><li>
4 + years of experience in the GMP pharmaceutical/biopharmaceutical industry</li></ul><br>
<div></div>
Pay Range:
<div><b>
$40-$50/hr</b></div>
Requisition Disclaimer:
<p>
This job posting is for a temporary role with a third-party agency partner on assignment at Vertex Pharmaceuticals (&ldquo;Vertex&rdquo;). The individual selected for this role will be offered the role as an employee of a third- party agency partner; compensation, medical benefits, fringe benefits and other terms and conditions of employment shall be presented by the third-party agency partner upon offer. The pay rate range provided is a reasonable estimate of the anticipated compensation range for this job at the time of posting. The actual pay rate will be based on a number of factors, including skills, competencies, experience, location and/or being pursued and other job-related factors permitted by law. In addition, this role will be eligible for overtime pay, in accordance with federal and state requirements</p><div></div><div><br>
By applying for this position, you agree to the Atrium Terms and Conditions and you direct Atrium to share your application materials, which may include your CV/Resume, email address or phone number, with Vertex. For more information on how Vertex handles your personal data related to your job application, please see Vertex&rsquo;s Careers Privacy Notice. Agreeing to the Atrium Terms and Conditions, includes permission to use the email address and mobile phone number you provide during the application process or throughout the duration of your prospective or actual employment to notify you of job openings, profiles, articles, news, and other employment-related information, as well as to notify you of special promotions or additional products and services offered by us or our affiliates and partners</div><div>
(collectively, &ldquo;Atrium Alerts&rdquo;). Atrium Alerts may be sent by email, phone, or text message. Your personal information will be safely stored within the Atrium &amp; Vertex databases. Atrium does not sell your personal information to third parties. Text message and data rates may apply. To OPT OUT of text messaging or to modify your communication preferences for Atrium Alerts at any time, please contact Atrium at privacyadministrator@atriumstaff.com.</div><div></div><p><br>
If you do not agree with the Atrium Terms and Conditions, you can still complete your application for this position by emailing your resume to our team at tempstaffing@vrtx.com. Please include the job title in the subject of your email.</p><div></div><div><b><br>
No C2C or Third-Party Vendors</b></div></div><div></div>

2nd shift Quality Control Specialist (contract) 28670

ENFRA

<div>About Us:
<p>
At ENFRA, we blend a rich history with a forward-looking vision. With over 100 years of experience, we are a pillar of stability in the energy infrastructure industry and a leader in innovative energy solutions. Our commitment to leveraging emerging technologies ensures that we remain at the forefront of the Energy-as-a-Service sector.</p><div></div><p><br>
We believe in growth&mdash;not just for our business, but for our people. Our team members have the opportunity to advance their careers in a supportive environment that values continuous learning and development. We embrace innovation and encourage creative problem solving to tackle the energy infrastructure and energy challenges of tomorrow.</p><div></div><p><br>
Inclusion is at the heart of our culture. We strive to create a workplace where every voice is heard and valued, fostering a collaborative environment where diverse perspectives drive our success.</p><div></div><p><br>
Join us to be part of a legacy of excellence and a future of groundbreaking advancements. At ENFRA, stability, innovation, and growth are more than just values&mdash;they are the pillars of our continued success.</p>
Overview:
<div>
The Quality Control Specialist II contributes to the overall success of the organization by ensuring products and services meet customers' expectations, regulatory requirements, project specifications, and the quality control program, The individual is expected to continuous improvement in safety outcomes, operational efficiency and team effectiveness.</div>
Responsibilities:
<ul><li>Quality Documentation: Managing and maintaining comprehensive documentations of quality control activities, inspections results, weld maps, torque maps and compliance records.</li><li>
Site QC Audits: The individual will be responsible for visual inspection to ensure the installed product meets project requirements, company standards and local codes. Thus, communicating any quality issues or concerns to supervisors, Foreman, and project managers to ensure that we meet customers specifications, local codes and standards.</li><li>
QC Project Reporting: Project reporting involves documenting and communicating project's unresolved issues and driving continuous improvement initiatives. The individual is responsible for enhancing product quality, reducing waste, optimizing processes, and increasing efficiency. This includes collaborating with project superintendents, Foreman and project managers to implement best practices and quality improvement.</li><li>
Review of project documents: This individual will review project documents for accuracy and completeness, checking for errors, inconsistencies, and missing information. They are responsible for ensuring that quality control processes and products comply with industry standards, local codes and customer specifications.</li><li>
Mentoring and Training: Provide knowledge, skills and guidance to Quality Control Specialist 1 and project team members.</li></ul>
Qualifications:
<h4 class="jobSectionHeader"><b>Required Education, Experience, and Qualifications</b></h4><ul><li>
4+ years' experience in fabrication shop quality control</li><li>
Quality Control training is required.</li><li>
OSHA 30</li><li>
20 hours Continuing Education</li><li>
Working knowledge of construction codes for mechanical, electrical, and plumbing.</li><li>
Working knowledge of regulatory agency requirements as it pertains to quality control.</li><li>
Working knowledge of nondestructive testing techniques.</li><li>
Ability to read and understand construction documents (contracts/subcontracts, purchase documents, plans, and specifications.).</li><li>
Ability to act as a specialist in quality control, keeping up with changes in the industry, and updating staff as well as corporate for any necessary procedural updates.</li><li>
Proven ability to supervise, communicate and lead personnel.</li><li>
Effective verbal and written communication skills.</li><li>
Detail-oriented and willing to tackle various ongoing projects in a fast-paced environment.</li><li>
Versed in the industry and the Company's competitors.</li><li>
Ability to multitask and perform duties outside of the scope of work when necessary.</li></ul><h4 class="jobSectionHeader"><b>
Preferred Education, Experience, and Qualifications</b></h4><ul><li>
4-year degree in a related field.</li><li>
5 years of hands-on experience in the layout, fitting, and welding steel pipe and sheet metal.</li><li>
Construction claims experience.</li><li>
Certifications (welding, quality control, nondestructive testing techniques, etc).</li><li>
Expert level knowledge of all welding methods, procedures, and quality control.</li><li>
Working knowledge of all tools and equipment.</li></ul><h4 class="jobSectionHeader"><b>
Travel Requirements</b></h4><ul><li>
0-5% of time will be spent traveling to job site(s)/office location.</li></ul><h4 class="jobSectionHeader"><b>
Physical/Work Environment Requirements</b></h4><ul><li>
Prolonged periods of sitting at a desk and working on a computer.</li><li>
Climbing stairs.</li><li>
Remaining in a stationary position, often kneeling, standing or sitting for prolonged periods.</li><li>
Repeating motions that may include the wrists, hands and/or fingers.</li><li>
Quiet environment.</li><li>
Light work that includes adjusting and/or moving objects up to 20 pounds.</li></ul>
Pay Range: USD $89,000.00 - USD $111,610.00 /Yr. EEO Statement:
<p>
ENFRA is proud to be an Equal Opportunity Employer of Minorities, Women, Protected Veterans, and Individuals with Disabilities, and participates in the e-Verify program. All qualified applicants will receive consideration for employment without regard to race, creed, color, religion, sex, age, sexual orientation, gender identity, national origin, veteran status, disability, or any other classification protected by law.</p></div>

Quality Control Spec. II

<div>About Us:
<p>
At ENFRA, we blend a rich history with a forward-looking vision. With over 100 years of experience, we are a pillar of stability in the energy infrastructure industry and a leader in innovative energy solutions. Our commitment to leveraging emerging technologies ensures that we remain at the forefront of the Energy-as-a-Service sector.</p><div></div><p><br>
We believe in growth&mdash;not just for our business, but for our people. Our team members have the opportunity to advance their careers in a supportive environment that values continuous learning and development. We embrace innovation and encourage creative problem solving to tackle the energy infrastructure and energy challenges of tomorrow.</p><div></div><p><br>
Inclusion is at the heart of our culture. We strive to create a workplace where every voice is heard and valued, fostering a collaborative environment where diverse perspectives drive our success.</p><div></div><p><br>
Join us to be part of a legacy of excellence and a future of groundbreaking advancements. At ENFRA, stability, innovation, and growth are more than just values&mdash;they are the pillars of our continued success.</p>
Overview:
<div>
The Quality Control Specialist I contributes to the overall success of the organization by ensuring products and services meet customers' expectations, regulatory requirements, project specifications, and the quality control program, The individual is expected to continuous improvement in safety outcomes, operational efficiency and team effectiveness.</div>
Responsibilities:
<ul><li>QC Documentation: The individual will input, maintain and track deficiencies within the QC software system.</li><li>
Site QC Audits: The individual will assist more senior technicians in troubleshooting problems and providing solutions of problems. They will be responsible for visual inspection to ensure the installed product meets project requirements, company standards and local codes.</li><li>
QC Project Reporting: Project reporting involves documenting and communicating the progress, findings and outcomes of quality control activities within the project.</li><li>
Review of Project Documents: This individual will review project documents for accuracy and completeness, checking for errors, inconsistencies, missing information that is related to the project drawings and specifications.</li><li>
Mentoring and Training: The individual will be expected to attend training sessions with the other QC and project team members. Quality Documentation: Managing and maintaining comprehensive documentations of quality control activities, inspections results, weld maps, torque maps and compliance records.</li><li>
Site QC Audits: The individual will be responsible for visual inspection to ensure the installed product meets project requirements, company standards and local codes. Thus, communicating any quality issues or concerns to supervisors, Foreman, and project managers to ensure that we meet customers specifications, local codes and standards.</li><li>
QC Project Reporting: Project reporting involves documenting and communicating project's unresolved issues and driving continuous improvement initiatives. The individual is responsible for enhancing product quality, reducing waste, optimizing processes, and increasing efficiency. This includes collaborating with project superintendents, Foreman and project managers to implement best practices and quality improvement.</li><li>
Review of project documents: This individual will review project documents for accuracy and completeness, checking for errors, inconsistencies, and missing information. They are responsible for ensuring that quality control processes and products comply with industry standards, local codes and customer specifications.</li></ul>
Qualifications:
<h4 class="jobSectionHeader"><b>Required Education, Experience, and Qualifications</b></h4><ul><li>
4-year degree in a related field.</li><li>
2+ years' experience in fabrication shop quality control</li><li>
Quality Control training is required.</li><li>
OSHA 10</li><li>
20 hours Continuing Education</li><li>
Working knowledge of construction codes for mechanical, electrical, and plumbing.</li><li>
Working knowledge of regulatory agency requirements as it pertains to quality control.</li><li>
Working knowledge of nondestructive testing techniques.</li><li>
Ability to read and understand construction documents (contracts/subcontracts, purchase documents, plans, and specifications.).</li><li>
Ability to act as a specialist in quality control, keeping up with changes in the industry, and updating staff as well as corporate for any necessary procedural updates.</li><li>
Proven ability to supervise, communicate and lead personnel.</li><li>
Effective verbal and written communication skills.</li><li>
Detail-oriented and willing to tackle various ongoing projects in a fast-paced environment.</li><li>
Versed in the industry and the Company's competitors.</li><li>
Ability to multitask and perform duties outside of the scope of work when necessary.</li></ul><h4 class="jobSectionHeader"><b>
Preferred Education, Experience, and Qualifications</b></h4><ul><li>
2+ years of hands-on experience in the layout, fitting, and welding steel pipe and sheet metal.</li><li>
Construction claims experience.</li><li>
Certifications (welding, quality control, nondestructive testing techniques, etc).</li><li>
Expert level knowledge of all welding methods, procedures, and quality control.</li><li>
Working knowledge of all tools and equipment.</li></ul><h4 class="jobSectionHeader"><b>
Travel Requirements</b></h4><ul><li>
0-5% of the time will be spent traveling to the job site(s)/office locations.</li></ul><h4 class="jobSectionHeader"><b>
Physical Activities</b></h4><ul><li>
Climbing stairs.</li><li>
Remaining in a stationary position, often standing or sitting for prolonged periods</li><li>
Repeating motions that may include the wrists, hands and/or fingers</li></ul><h4 class="jobSectionHeader"><b>
Environmental Conditions</b></h4><ul><li>
Quiet environment</li></ul><h4 class="jobSectionHeader"><b>
Physical Demands</b></h4><ul><li>
Light work that includes adjusting and/or moving objects up to 20 pounds</li></ul>
Pay Range: USD $50,500.00 - USD $70,000.00 /Yr. EEO Statement:
<p>
ENFRA is proud to be an Equal Opportunity Employer of Minorities, Women, Protected Veterans, and Individuals with Disabilities, and participates in the e-Verify program. All qualified applicants will receive consideration for employment without regard to race, creed, color, religion, sex, age, sexual orientation, gender identity, national origin, veteran status, disability, or any other classification protected by law.</p></div>

Quality Control Spec. I

MiGenTra Egypt

<div>
 <p>
  <strong>
   <em>
    <u>
     About Minapharm
    </u>
   </em>
  </strong>
 </p>
 <p>
  Minapharm Pharmaceuticals is a leading pharmaceutical company in Egypt and the Middle East with its subsidiary Rhein Minpahrm Biogenetics the premier biopharmaceutical company in Africa with over 20 years of experience in cellular and bioprocess engineering. Headquartered in Cairo, Minapharm commercializes over 100 life-saving and life-enhancing products ranging from small molecules to complex genetically engineered proteins, with an impressive immunotherapy pipeline. Minapharm&rsquo;s wholly-owned Berlin-based subsidiary, ProBioGen AG, is a world-renowned contract development and manufacturing organization (CDMO), a cell line-engineering specialist, and a provider of proprietary protein and viral vector technologies to large pharma and the global biotech industry. Minapharm has established an integrated business model making it to date the only gene-to-market biopharmaceutical company in the region. Minapharm employs a collective workforce of over 1400 individuals.
 </p>
 <p>
  <strong>
   <em>
    <u>
     Our Values:
    </u>
   </em>
  </strong>
 </p>
 <p>
  &middot; Diversity &amp; Respect
 </p>
 <p>
  &middot; Integrity &amp; Accountability
 </p>
 <p>
  &middot; Collaboration
 </p>
 <p>
  &middot; Leadership &amp; Empowerment
 </p>
 <p>
  &middot; Innovation &amp; Continuous Learning
 </p>
 <p>
  <br/>
 </p>
 <p>
  <strong>
   MiGenTra Egypt is hiring several positions in the QA Department.
  </strong>
 </p>
 <p>
  <br/>
 </p>
 <p>
  <strong>
   <em>
    <u>
     Responsibilities &amp; Duties for QA Compliance Specialist:
    </u>
   </em>
  </strong>
 </p>
 <ul>
  <li>
   Participate in update procedures relevant to pharmaceutical quality system compliance, gap analysis, internal audits, supplier audits, quality risk management and GMP training.
  </li>
  <li>
   Participate in annual internal audit schedule, prepare internal audit reports, send approved internal audit reports to owners, agree with owners on SMART CAPAs, follow up closure of CAPA and evaluate CAPA effectiveness and quarterly report status of internal audit QKPIs.
  </li>
  <li>
   Participate in audits of supplier / contractor / contract acceptors, prepare audit reports, send approved audit reports to supplier / contractor / contract acceptors, agree with them on SMART CAPAs, follow up closure of CAPA and evaluate CAPA effectiveness and quarterly report status of supplier / contractor / contract acceptors audit QKPIs.
  </li>
  <li>
   Ensure that all employees (permanent, temporary) and contractor / visitors receive required GMP training before they independently certified to perform their tasks independently.
  </li>
  <li>
   Prepares a register of qualified trainers, participate in preparation of training programs, participate in evaluation of training effectiveness and quarterly report status of GMP training QKPIs.
  </li>
  <li>
   Participate in all quality risk management activities with cross-functional teams of SMEs. Follow-up closure of all actions required to reduce risks to an acceptable level and evaluate effectiveness of these actions through after action risk review. Quarterly report status of quality risk management QKPIs.
  </li>
  <li>
   Work with cross-functional team to develop and maintain site contamination control strategy. Prepare a quarter report indicating status of contamination control strategy and its effectiveness in controlling contamination and cross-contamination risks and recommendations for improvement.
  </li>
  <li>
   Perform PQR data collection, review, analysis and reporting for all manufactured products. Set recommended actions and required SMART CAPA with follow up closure of CAPA and evaluate CAPA effectiveness and quarterly report status of PQR reports in QKPIs.
  </li>
  <li>
   Handling of received Customer Complaints ( starting from receiving of complaint, numbering, evaluation and investigation, impact assessment, set SMART CAPA, immediate action and CAPA follow up, closure and trending )
  </li>
  <li>
   Participate in different multidisciplinary teams and relevant activities as required.
  </li>
  <li>
   Perform other relevant tasks as required.
  </li>
 </ul>
 <p>
  <br/>
 </p>
 <p>
  <strong>
   <em>
    <u>
     Responsibilities &amp; Duties for QA - IPC Specialist:
    </u>
   </em>
  </strong>
 </p>
 <ul>
  <li>
   Review Batch record to ensure compliance of finished product.
  </li>
  <li>
   Perform inspection in production area , raw materials and finished product warehouse.
  </li>
  <li>
   Participate in non-conformities investigations to reach the root cause and set required CAPA.
  </li>
  <li>
   Participate in investigate of customer complaints and/or products recall.
  </li>
  <li>
   Perform supplier audits for primary and secondary packaging local supplier.
  </li>
  <li>
   Perform any additional tasks as requested.
  </li>
 </ul>
 <p>
  <br/>
 </p>
 <p>
  <strong>
   <u>
    Responsibilities &amp; Duties for Internal Audit Specialist:
   </u>
  </strong>
 </p>
 <ul>
  <li>
   Ensure that Document Control System / Change control systems are properly implemented
  </li>
  <li>
   Ensure adherence to all relevant rules and regulations
  </li>
  <li>
   Issue new relevant SOPs and revise the approved SOP according to revision plan.
  </li>
  <li>
   Execute quality risk management projects.
  </li>
  <li>
   Prepare protocol, execute qualification protocols and report outcomes for Equipment / Utilities qualification.
  </li>
  <li>
   Report outcomes of process validation and cleaning validation activities.
  </li>
  <li>
   Report outcomes of production area qualification and steam sterilization qualification activities.
  </li>
  <li>
   Prepare protocols, execute and report thermal mapping activities.
  </li>
 </ul>
 <p>
  <br/>
 </p>
 <p>
  <strong>
   <em>
    <u>
     Qualifications:
    </u>
   </em>
  </strong>
 </p>
 <ul>
  <li>
   Bachelor degree in Pharmaceutical Sciences or Biotechnology.
  </li>
  <li>
   <strong>
    Experience:
   </strong>
  </li>
  <li>
   Specialist : 0-3 years of experience of relevant experience.
  </li>
  <li>
   Sr Specialist : 3-6 years of relevant experience.
  </li>
  <li>
   Basic cGMP guidelines.
  </li>
 </ul>
 <p>
  <br/>
 </p>
 <p>
  <strong>
   Location
  </strong>
  : 10th of Ramadan City, Egypt (Transportation Provided).
 </p>
</div>


Quality Assurance Specialist (Compliance / In Process control / Internal Audit)

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