Quality Specialist – Dow Pharmaceutical Sciences – Bridgewater, NJ, USA
The QA Product Release Associate will work in the External QA team of Valeant United States (US) Quality Assurance. This unit includes oversight of external drug product manufacturing at contract manufacturers, laboratory operations, internal warehouse operations, packing and labeling operations, batch release and logistics performed on behalf of Valeant. This unit also provides QA support for Quality Control (drug substance, drug product testing and stability).
This individual will support all disposition activities related to external commercially manufactured, drug substance, drug product and finished drug. Responsible for adhering to domestic and international GMP regulations and cGMP’s, company policies.
Responsibilities: This position is responsible for 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 minor non-conformances/ deviations
• May own CAPAs associated within the QA unit
• Prepare drug product annual review report sections
• Understanding of GMP’s
• Initiate non-conformances, CAPAs and Change Management.
• Supports departmental projects, as needed
Scope of position:
The scope of this position is directly related to the Valeant North America External Manufacturing and the EMEA Supplier Quality Organization.
The position has no supervisory responsibilities.
The position will include routine interaction and communication with internal business stakeholders (Quality, Compliance, Supply Chain, R&D, Regulatory and Commercial) and external business partners (External Manufacturing groups).
Qualifications: Bachelor’s degree in a technical, preferably a biological science discipline and biopharmaceutical industry experience.
• 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.
Minimum requirements include a Bachelor’s degree in a technical, preferably a biological science discipline and a minimum of 2 years biopharmaceutical industry experience.
Periodic domestic travel is required for business meetings with regional Quality team, corporate peers/collaborators, vendors/contractors, and to stay current with professional development opportunities.