What are the responsibilities and job description for the Batch Record Reviewer/ Deviations SME position at Tunnell Consulting?
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.
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 QA Batch Record Review/Deviations SME. This is estimated to be a minimum 3-month project with potential for extension. Onsite is required; location Rockville, MD area. Local candidates preferred.
Title: QA Batch Record Review/Deviations SME
Role:
The QA Batch Record Review/Deviations SME will review batch records for completeness and accuracy as well as assessing any identified manufacturing deviations.
The incumbent will be responsible for conducting and documenting GMP investigations including generation, closing and effectiveness checks of CAPAs for a pharmaceutical manufacturer in their respective areas, including evaluating product impact, conducting the cross functional root cause analysis effort, authoring the investigation and shepherding it for review and approval. Ensure that the investigation process used adheres to the client's policies and SOPs.
Skills:
- 5 years of relevant QA experience supporting commercial GMP manufacturing.
- Experienced performing batch record review and knowledge of GMP deviation identification.
- Direct, hands-on experience with deviations/investigations/CAPA authoring.
- General knowledge of biotech/biologic manufacturing processes.
Education:
- Bachelor's degree in engineering or scientific discipline.
Tunnell is proud to be an Equal Opportunity / 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 certain client contracts may outline specific requirements for onsite work. Tunnell employees and/or contractors are expected to comply with all client requirements, including any safety and health protocols.
