Senior QA Specialist - C&Q

Johnson & Johnson Innovative Medicine•Wilson, NC

5d•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 position provides Quality Assurance oversight to commissioning, qualification and validation (C&Q) activities across the capital project lifecycle and supports compliance with current Good Manufacturing Practices, regulatory requirements, company policies and internal procedures. The role contributes to establishing the site's validation program and quality management system, preparing the facility for handover and licensure, and transitioning systems into ongoing validation.

Requirements

Bachelor's degree in a scientific or engineering discipline and at least six years of experience, or a Master's degree and at least four years of experience, within 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 (URS, CARA, FAT, SAT, IQ, OQ and PQ) and 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, with proficiency in FMEA, HACCP, HAZOP and ICH Q9(R1) quality risk management.
Proficiency in technical writing for validation and quality documents.
Integrity and commitment to ethical conduct and compliance with regulatory requirements.
Sound, detail-oriented, risk-based QA judgment, balancing product quality and patient safety with 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

Proven expertise as a C&Q subject matter expert in 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 systems for visual inspection, device assembly, and secondary/tertiary packaging.
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 oversee C&Q and validation execution from user requirements and design review 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 documents, IQ/OQ/PQ protocols and reports, and analytical, cleaning, process and sterilization validation protocols and reports.
Ensure good documentation practice and data integrity for vendor, EPCM and CQV contractor documentation used as Good Engineering Practice evidence.
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, environmental monitoring performance qualification, and visual inspection qualification.
Review and approve single-use system qualification, including supplier documentation and extractables/leachables assessments.
Support development and implementation of the site's 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 temperature mapping of 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.
Serve 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 BLA/sBLA licensure path for the new facility.
Review and approve Technology Transfer documents and support transition from C&Q to ongoing validation, 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 internal cross-functional teams and external partners to address quality issues and implement compliance 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.