QA Shopfloor (REV) at Tunnell Consulting

Posted in General Business 11 days ago.

Type: Full-Time
Location: San Diego, California

Job Description:

Tunnell Consulting is an employee-owned, life sciences management consulting firm. Known for solving complex problems in the life sciences, we support the mission and objectives of a variety organizations including biotech, pharma, the U.S. Government, foundations, public/private partnerships, investors, and emerging companies. The variety of clients and issues that we support give our team and our organization an ever-increasing breadth of experience to add to our deep industry and functional expertise. Headquartered in the Philadelphia area, we also have a presence in Washington DC, and Boston.

Turesol, the staffing division of Tunnell Consulting, looks for top talent on behalf of our Pharmaceutical/Biotech clients. Currently, one of our client's need a Shopfloor QA Support Specialist. This is for a Swing/3 rd Shift contract role with potential for Temp to Perm.Client is located in the greater San Diego area. Work will be performed onsite.

The Shopfloor QA Support Specialist is responsible for quality activities supporting Manufacturing Operations. Activities include but not limited to:

  • Review and assess manufacturing documents for compliance with GMP regulations and SOPs (review of batch records for completeness and errors, review of change control documents, manufacturing deviation support, review of qualification/validation documentation, participation in audits...).
  • Review and assess manufacturing documents, materials and activities against regulations, SOPs, equipment and facilities.
  • Work with Manufacturing Operations to resolve issues.


  • 2+ years of relevant QA experience supporting commercial GMP manufacturing.
  • Experience with one or several production quality management systems (batch record review and release, deviations/investigations/CAPA/change control, qualification and validation, data integrity, sterility assurance, audits).
  • Solid knowledge of GMP for commercial manufacturing.


  • Bachelor's degree in engineering or scientific discipline.

Tunnell is proud to be an Equal Opportunity / Affirmative Action / Female / Minority / Disabled / Veteran Employer and does not discriminate on the basis of race, color, religion, sex (including pregnancy, child-birth, or related medical conditions), national origin, ancestry, age, disability, family care status, veteran status, marital status, military status, sexual orientation, gender identity, or any other characteristic protected by law. Tunnell makes reasonable accommodation for persons with disabilities to apply for employment.

Please be advised that Tunnell employees are required to be fully vaccinated against COVID-19 as per CDC guidelines and subject to legal requirements. In accordance with Tunnell's COVID-19 Vaccination Policy, employees need to confirm that they are fully vaccinated or engage in an interactive dialogue with Human Resources to determine eligibility for a religious or medical exception, and whether making such an exception would pose an undue burden or undue risk of harm. Additionally, client-facing employees are also expected to comply with all current and future client requirements for COVID-19 safety, including but not limited to surveillance testing, masking requirements, social distancing, and any other requirements.

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