Senior QA Specialist - C&Q

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Job Function:
Quality

Job Sub Function:
Quality Assurance

Job Category:
Professional

All Job Posting Locations:
Wilson, North Carolina, United States of America

Job Description:

We are currently seeking a highly qualified individual to join our team as a Senior QA Specialist - C&Q at our new Biotherapeutics Manufacturing facility in Wilson, North Carolina (BioNC).

Essential Job Duties and Responsibilities

This position is responsible for ensuring compliance with regulatory requirements and company policies following current Good Manufacturing Practices, Johnson & Johnson Policies and internal procedures through the following duties and responsibilities:

C&Q Lifecycle and Validation Program

• Represents Quality Assurance on qualification teams and provides QA oversight of C&Q and validation execution across the capital project lifecycle-user requirements, design review, construction, FAT/SAT, commissioning, qualification and handover-including leveraging commissioning (Good Engineering Practice) documentation into qualification per ASTM E2500 and the ISPE Baseline Guide Vol.

5 (2nd Ed.), in compliance with GMP, FDA, EMA and other regulatory requirements.

• Supports the development and maintenance of the site validation program, Validation Master Plan, and project C&Q and validation plans, ensuring alignment with regulatory and corporate requirements and with project timelines and deliverables.

• Participates in risk assessments (e.g., FMEA, HACCP, HAZOP, ICH Q9(R1) quality risk management, and CARA) for equipment, utilities and systems; performs QA review of system impact assessments and equipment/utility categorization; helps define critical aspects and critical design elements; and reviews requirements traceability matrices.

• Reviews and approves commissioning and qualification documentation, including User Requirements Specifications (URS), FAT/SAT documentation, and Installation, Operational and Performance Qualification (IQ/OQ/PQ) protocols and reports, as well as validation protocols and reports (analytical, cleaning, process, sterilization, etc.).

• Ensures Good Documentation Practice and data integrity of ven...