Sr. Quality Assurance Specialist
Direct Hire

Our client, an international pharmaceutical manufacturing company is looking to add a Senior Quality Assurance Specialist to the team at Pennsville, NJ, which is their drug substance manufacturing site for the US market.

– Reviews and approves executed production records, production investigations, Master Production Records, COAs and DMFs
– Reviews lab sample results and manufacturing records relative to qualification/validation activities.
– Conducts, writes, and reviews quality related investigations
– Responsible for cGMP compliance of assigned manufacturing operations / areas and conducts cGMP inspections
– Completes pre-campaign action items as assigned.
– Responsible for the conditional / final release of materials
– Reviews finished product labels. Prepares and reviews product trees
– Writes and reviews Product Validation / Qualification / Equipment Qualifications / Assessments documents and Computerized Systems Validations
– Reviews, evaluate and approves minor equipment changes
– Conducts environmental monitoring
– Maintains QA databases for products / equipment

– BA/BS degree in microbiology (preferred), biology, chemistry, or engineering
– 3-5 years of experience in auditing in a pharmaceutical manufacturing environment, (or an equivalent combination of education and experience)
– Thorough knowledge of cGMP is required