Senior QA Specialist - C&Q

Johnson & Johnson•Wilson, NC

3d•Onsite

About The Position

Johnson & Johnson is seeking a Senior QA Specialist – C&Q for its new Biotherapeutics Manufacturing facility in Wilson, North Carolina. The role ensures compliance with current Good Manufacturing Practices, company policies, internal procedures, and applicable regulatory requirements. It provides Quality Assurance oversight across commissioning and qualification (C&Q), validation, aseptic processing, sterility assurance, facility and utility readiness, and quality systems throughout the capital project lifecycle and into ongoing operations. The position represents QA on qualification teams, supports the site validation program and Validation Master Plan, reviews and approves C&Q and validation documentation, and provides risk-based oversight of equipment, utilities, systems, and facilities. It also supports contamination control, inspection readiness, licensure activities, technology transfer, and the transition from project qualification to the ongoing validation lifecycle. The role works closely with Operations, Engineering and Maintenance, Validation, Automation, MSAT, QC, external engineering and CQV contractors, and equipment vendors. It also helps establish the site quality management system and validation program by developing procedures, work instructions, forms, and tools. The position oversees a broad range of GMP systems, including aseptic processing and packaging equipment, sterilization and decontamination systems, cleanrooms, HVAC, utilities, controlled-temperature storage, and warehouse systems.

Requirements

Bachelor's degree in a scientific or engineering discipline with at least six years of experience, or a master's degree with at least four years of experience, in the biological and/or pharmaceutical industry.
QA or validation experience on C&Q projects for sterile or aseptic drug product manufacturing equipment, such as parenteral fill-finish.
Hands-on experience with the qualification and validation lifecycle, including URS, CARA, FAT, SAT, IQ, OQ, and PQ, and with cleaning/process validation, including review and approval of protocols and reports.
Strong understanding of cGMP (21 CFR 210/211 and 600s) and FDA, EMA, and ICH guidelines, including ICH Q9(R1) and Q10.
Working knowledge of EU GMP Annex 1 (2022), including the Contamination Control Strategy, EU GMP Annex 15, and FDA 2004 Guidance for Sterile Drug Products Produced by Aseptic Processing.
Familiarity with risk-based C&Q and validation lifecycle standards and guidance, including ASTM E2500, ISPE Baseline Guide Vol. 5 (2nd Ed.), and GAMP 5 (2nd Ed.).
Working knowledge of computerized system validation/assurance, 21 CFR Part 11, EU Annex 11, and ALCOA+ data integrity principles.
Strong understanding of risk-based commissioning and qualification/validation approaches and proficiency in risk management methodologies such as FMEA, HACCP, HAZOP, and ICH Q9(R1) quality risk management.
Proficiency in technical writing for validation and quality documents.
High integrity and commitment to ethical conduct and compliance with regulatory requirements.
Sound, detail-oriented, risk-based QA judgment, maintaining product quality and patient safety while enabling schedules through pragmatic, right-first-time solutions.
Ability to thrive in ambiguity and a fast-paced start-up environment, build processes from the ground up, and independently manage shifting priorities and deadlines with minimal supervision.
Excellent communication and relationship-building skills, including the ability to influence cross-functional teams, contractors, and vendors without direct authority and interact effectively at all organizational levels.

Nice To Haves

Subject matter expertise in C&Q for regulated industries.
Experience supporting a greenfield or start-up sterile manufacturing facility through C&Q, handover, and licensure.
Hands-on QA experience with isolator filling lines and automated visual inspection, device assembly, and secondary/tertiary packaging systems.
Working knowledge of ISO 14644, USP <790>/<1790>, and relevant PDA Technical Reports such as TR 1, TR 22, and TR 26.
Experience with paperless validation platforms such as Kneat.
Experience supporting regulatory inspections, including pre-approval or pre-license inspections.
ASQ certification, such as CQA or CQE, and/or active involvement in ISPE.

Responsibilities

Represent Quality Assurance on qualification teams and provide QA oversight of C&Q and validation through the capital project lifecycle, from requirements and design through construction, FAT/SAT, commissioning, qualification, and handover.
Support development and maintenance of the site validation program, Validation Master Plan, and project C&Q and validation plans.
Participate in risk assessments for equipment, utilities, and systems; review system impact assessments, equipment and utility categorization, critical aspects, critical design elements, and requirements traceability matrices.
Review and approve commissioning, qualification, and validation documentation, including URS, FAT/SAT documentation, IQ/OQ/PQ protocols and reports, and analytical, cleaning, process, and sterilization validation documents.
Ensure Good Documentation Practice and data integrity for vendor, EPCM, and CQV contractor documentation used as Good Engineering Practice evidence in qualification.
Provide QA oversight of sterilization and decontamination qualification, including autoclave and SIP cycles, E-beam irradiation, and VHP decontamination cycle development with biological indicators.
Provide QA oversight of aseptic process simulations, sterile filtration and filter validation including PUPSIT, cleanroom classification, airflow visualization studies, and environmental monitoring performance qualification.
Provide QA oversight of visual inspection qualification, including defect libraries and manual-versus-automated inspection comparison studies.
Review and approve single-use system qualification, including supplier documentation and extractables/leachables assessments.
Support development and implementation of the site Contamination Control Strategy in alignment with EU GMP Annex 1.
Provide QA oversight of utility and facility qualification, including WFI, clean steam, process gases, and HVAC.
Review and approve temperature mapping for cold storage and controlled-temperature equipment and areas.
Review turnover packages and manage QA disposition of punch-list items, discrepancies, and qualification readiness before system handover.
Support QA setup of calibration and preventive maintenance programs, including onboarding qualified assets.
Act as the QA point of contact for deviations, CAPAs, and change controls related to C&Q and validation activities.
Support PPQ, pre-approval and pre-license inspection readiness, and the facility's BLA/sBLA licensure path.
Review and approve Technology Transfer documents for regulatory and company compliance.
Support transition from C&Q into the ongoing validation lifecycle, including periodic review and requalification.
Provide QA support and direction to project, engineering, and C&Q teams on quality system elements.
Develop and implement C&Q and validation processes, procedures, forms, work instructions, and tools for the site quality management system and validation program.
Collaborate with cross-functional teams and external partners to address quality issues and implement compliant systems efficiently.
Review and approve SOPs, work instructions, and quality management system documents.
Recommend process improvements to enhance compliance and efficiency in C&Q and validation activities.