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 vendor, EPCM and CQV contractor documentation leveraged as Good Engineering Practice evidence in qualification.

Aseptic Processing and Sterility Assurance

· Provides QA oversight of sterilization and decontamination qualification, including autoclave and SIP cycles, E-beam irradiation, and vaporized hydrogen peroxide (VHP) decontamination cycle development with biological indicators.

· Provides QA oversight of aseptic process simulations (media fills), sterile filtration and filter validation (including PUPSIT), cleanroom classification, airflow visualization (smoke) studies, and environmental monitoring performance qualification.

· Provides QA oversight of visual inspection qualification, including defect libraries and manual-versus-automated inspection comparison studies.

· Reviews and approves single-use system qualification, including evaluation of supplier documentation and extractables/leachables assessments.

· Supports development and implementation of the site Contamination Control Strategy (CCS) in alignment with EU GMP Annex 1.

Utilities, Facility and Operational Readiness

· Provides QA oversight of utility and facility qualification, including water for injection (WFI) and clean steam (including phased water system PQ), process gases, and HVAC.

· Reviews and approves temperature mapping of cold storage and controlled-temperature equipment and areas (e.g., refrigerators, freezers, cold rooms).

· Reviews turnover packages and manages QA disposition of punch-list items, discrepancies and qualification readiness prior to system handover.

· Supports QA set-up of the calibration and preventive maintenance programs, including onboarding of qualified assets.

Quality Systems, Licensure and Lifecycle

· Acts as the QA point of contact for deviations, CAPAs and change controls related to C&Q and validation activities.

· Supports process performance qualification (PPQ), pre-approval/pre-license inspection readiness, and the BLA/sBLA licensure path for the new facility.

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