# Senior QA Specialist - C&Q at Johnson & Johnson

Johnson & Johnson is hiring a Senior QA Specialist - C&Q. Level rates it Little AI ●○○○; you can [apply on Johnson & Johnson](https://jobsbylevel.com/go/71dd688a-25cc-42db-98d5-3a376ddfafc8?utm_medium=ai-agent).

AI Level 1, AI centrality 35 out of 100. Wilson, North Carolina, United States of America.

## Details

- Company: [Johnson & Johnson](https://jobsbylevel.com/companies/johnson-johnson)
- AI level: AI Level 1 (score 35 out of 100)
- Location: Wilson, North Carolina, United States of America
- Posted: November 4, 2026
- Apply: https://jobsbylevel.com/go/71dd688a-25cc-42db-98d5-3a376ddfafc8?utm_medium=ai-agent
- Free CV review for this job: https://jobsbylevel.com/cv-review?job=senior-qa-specialist-c-q-at-johnson-johnson-f749e2

## 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

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Source: https://jobsbylevel.com/jobs/senior-qa-specialist-c-q-at-johnson-johnson-f749e2

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