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.

·       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 engineering discipline with a minimum of six (6) years of experience, or a Master's degree with a minimum of four (4) years of experience, within the biological and/or pharmaceutical industry.

·       QA or validation experience on C&Q projects for sterile/aseptic drug product manufacturing equipment (e.g., fill-finish of parenteral products).

·       Hands-on experience with the qualification/validation lifecycle (URS, CARA, FAT, SAT, IQ, OQ, PQ) and cleaning/process validation, including reviewing and approving 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 the FDA 2004 Guidance for Sterile Drug Products Produced by Aseptic Processing.

·       Familiarity with industry standards and guidance for risk-based C&Q and validation lifecycle principles, including ASTM E2500 and the ISPE Baseline Guide Vol. 5 (2nd Ed.) and GAMP 5 (2nd Ed.).

·       Working knowledge of computerized system validation (CSV/CSA), 21 CFR Part 11, EU Annex 11 and data integrity (ALCOA+) principles.

·       Strong understanding of risk-based approaches to commissioning and qualification/validation, with 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.

 

Preferred Qualifications

·       Proven expertise as a Subject Matter Expert 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 systems for visual inspection, device assembly, and secondary/tertiary packaging.

·       Working knowledge of ISO 14644 (cleanrooms), USP <790>/<1790> (visual inspection) and relevant PDA Technical Reports (e.g., TR 1, TR 22, TR 26).

·       Experience with paperless validation platforms (e.g., Kneat).

·       Experience supporting regulatory inspections, including pre-approval or pre-license inspections.

·       ASQ certification (e.g., CQA, CQE) and/or active involvement in ISPE.

 

Other requirements

• An unquestionable level of integrity and commitment to operating ethically and within the boundaries of regulatory requirements.
• Exercises sound, detail-oriented, risk-based QA judgment—holding firm on product quality and patient safety requirements while enabling schedule through pragmatic, right-first-time solutions.
• Thrives in ambiguity and a fast-paced start-up environment; builds processes from the ground up and manages multiple, shifting priorities and deadlines independently with minimal supervision.
• Excellent communication and relationship-building skills, with the ability to influence cross-functional teams, contractors and vendors without direct authority and to interact effectively with all levels of the organization.

Johnson & Johnson is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, disability, protected veteran status or other characteristics protected by federal, state or local law. We actively seek qualified candidates who are protected veterans and individuals with disabilities as defined under VEVRAA and Section 503 of the Rehabilitation Act.

Johnson & Johnson is committed to providing an interview process that is inclusive of our applicants’ needs. If you are an individual with a disability and would like to request an accommodation, please contact us via https://www.jnj.com/contact-us/careers or contact AskGS to be directed to your accommodation resource.

#Onsite

 

 

Required Skills:

 

 

Preferred Skills: