Principal QA Specialist

Must Haves:

• Bachelor's Degree and 10+ years of experience OR Master's Degree and 8+ years’ experience in a QA cGMP regulated environment within Biopharmaceuticals or equivalent.
• Experience in a QA role supporting Manufacturing Process Operations and validations is required.
• Knowledge of US, EU and cGMP guidelines is required.
• Working knowledge of electronical management systems, Operational Excellence

Job Description:

Insight Global is seeking a Principal Quality Assurance Specialist for a biopharmaceutical client in Durham, NC. The QA Specialist is responsible for providing Quality Assurance support to Manufacturing Process Operations. Performs document review and approval of Master Batch Records, SOP’s and Technical Documents. Collaborate directly with MS&T and Manufacturing to support BOM review and approvals to meet timelines.

Responsibilities:

• Reviews and approves the following records in support of manufacturing operations: Master Batch, Solution, Equipment Preparation, Process Assembly Records, Test Sampling Plans and other manufacturing records as needed.
• Supports BOM review, approval, and release within ASCTrac/SAP.
• Reviews and approves Technical Documents associated with process validation and manufacturing operations, including but not limited to the following document types: Process Characterization, Process Performance Qualification, Resin and Membrane Qualifications, and Non-routine Sample Plans.
• Provides general QA support to manufacturing operations, which includes deviation investigations, CAPAs, procedures and change control assessments, as required.
• Performs compliance review of executed batch records and internal support records, as needed.
• Attend relevant project and operational meetings. Support client audits, client meetings, regulatory inspections, and process improvement projects, as required.
• Supports training and mentoring of other Quality department staff to perform quality duties, as needed.