Senior QA Specialist - C&Q

Job description

At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at jnj.com. As guided by Our Credo, Johnson & Johnson is responsible to our employees who work with us throughout the world. We provide an inclusive work environment where each person is considered as an individual. At Johnson & Johnson, we respect the diversity and dignity of our employees and recognize their merit. 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. ·       Reviews and approves Technology Transfer documents, ensuring they meet regulatory and J&J requirements. ·       Supports the transition from C&Q into the ongoing validation lifecycle, including periodic review and requalification. Additional Job Duties and Responsibilities ·       Provides QA support and direction to project, engineering and C&Q teams on specific quality system elements to ensure business, quality and compliance goals are met following J&J Standards. ·       Develops and implements C&Q and validation processes, procedures, forms, work instructions and tools in support of standing up the site quality management system and validation program. ·       Collaborates with cross-functional teams (Operations, Engineering & Maintenance, Validation, Automation, MSAT, QC, etc.) and external partners (EPCM firms, CQV contractors and equipment vendors) to address quality issues and ensure compliance systems are implemented efficiently. ·       Reviews and approves standard operating procedures (SOPs), work instructions and quality management system documents to ensure accuracy and compliance. ·       Recommends process improvements to enhance compliance and efficiency in C&Q and validation activities. Systems in Scope 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 Minimum Qualifications ·       Bachelor's degree in a scientific or eng