QA Batch Record Review/ Deviations (Finance)
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 required.
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 strives to hire and retain the most qualified talent. We believe that having employees with different backgrounds and capabilities contributes to the success of our business. To attract qualified applicants, Tunnell posts to a wide variety of job sites. 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.
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.
