Quality Manager – Product Release Dow Pharmaceutical – Bridgewater, NJ, USA
The position is responsible for oversight of review and release of all records associated with external manufactured products. Supports all pharmaceutical supply channels including, cold chain and evaluation of cold chain as related to movement of plasma and plasma derived drug product to the end user. The individual may be responsible for, but is not limited to:
• Product batch disposition preparation in accordance with priorities and inventory demands.
• Conducting record review of executed batch records from CMO operations; if required support CMO packaging & labeling record review,
• Performing review of records e.g CoA, CoC, testing results,…
• Review all non-conformances/ deviations
• May own/ approve CAPAs associated within the QA unit
• Review drug product annual review report sections
• Understanding of GMP’s
• Supports departmental projects, as needed
Qualifications: A minimum of a Bachelor’s degree in a technical, preferably Biological, Chemistry, Pharmacy required.
8 plus years biopharmaceutical industry experience. Previous experience in the supervision of QA/QC activities is preferred.
Qualified Candidates Will Have
• Critical thinking/ evaluation of process problems
• Data trending and evaluation
• Ability to multi-task in environment with changing priorities
• Strong work ethic
• Proactively addressing compliance issues and assuming responsibility for compliance deficiencies.
• Actively leading “Lessons Learned” activities.
• Ability to develop gap analysis and action plans.