Senior QA Specialist - C&Q

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).

·       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.

·       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.

·       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.

The role provides QA oversight across the following GMP systems. Experience with every system is not required.

·       Aseptic processing equipment – isolator-based filling lines, GMP parts washers, capping/crimping, stopper processing, compounding/formulation vessels, and single-use mixing and transfer systems

·       Sterilization and decontamination – autoclaves, E-beam, SIP/CIP, and VHP decontamination

·       Automated and semi-automated visual inspection

·       Combination product device assembly – automated pre-filled syringe (PFS) assembly equipment, including plunger rod insertion, autoinjector/safety device assembly, and in-line vision and functional testing

·       Secondary packaging – labeling, cartoning, serialization and aggregation (DSCSA), case packing, and associated vision and print inspection systems

·       Facility and controlled environments – cleanrooms, HVAC, LAF and BSC units, environmental monitoring systems and BMS/EMS

·       Utilities and supporting equipment – water for injection, clean steam, process gases, refrigerators and freezers

·       Incoming goods handling – automated re-palletization equipment for transferring received materials and components from supplier pallets onto GMP-compliant pallets, including label/barcode verification and integration with the warehouse management system

·       Warehousing and storage – ambient and cold room (2–8 °C) automated storage and retrieval systems (ASRS), including temperature mapping and monitoring, material status control, and integration with warehouse management and ERP systems