Analyst 3 - Quality Assurance

Johnson & Johnson•Wilson, NC

About The Position

The QA Specialist, Commissioning and Qualifications (C&Q), supports the Wilson, North Carolina site’s quality and compliance programs. The position ensures that site validation activities comply with regulatory requirements, company policies, current Good Manufacturing Practices, and internal procedures. It represents Quality Assurance throughout project requirements, design review, construction, qualification, cleaning development and validation, and project implementation. The role provides quality oversight for commissioning, qualification, computer systems validation (CSV), and validation execution, and supports plans that align with project timelines and deliverables. It also contributes to site compliance systems and collaborates with engineering, validation, manufacturing, operations, maintenance, MSAT, and QC teams to address quality matters. The position is listed for an 18-month duration.

Requirements

Bachelor’s degree in a scientific or engineering discipline.
Two to four years of experience in the biotherapeutic and/or pharmaceutical industry.
Knowledge of compliance requirements for commissioning, qualification, and validation of GMP processes and systems.
Experience or knowledge involving utilities such as water for injection, clean steam, process gases, HVAC, SIP/CIP; fridges, freezers, LAF and BSC units, autoclaves and isolators; and process equipment such as bioreactors, UF/DF, centrifuges, and chromatography systems.
Strong understanding of cGMP, FDA, EMA, and ICH guidelines and ISPE Baseline Guides.
Hands-on experience with the qualification and validation lifecycle, including URS, FAT, SAT, IQ, OQ, and PQ, and with cleaning and process validation.
Familiarity with ISPE guidelines, including GAMP 5 and ASTM E2500, and validation lifecycle principles.
Strong understanding of risk-based approaches to commissioning and qualification/validation.
Proficiency in technical writing for validation and quality documents.
Strong communication and interpersonal skills for cross-functional collaboration.
High integrity and commitment to ethical conduct and regulatory requirements.
Ability to manage multiple priorities and work independently with minimal supervision.
Detail-oriented mindset and ability to identify process improvement opportunities.
Ability to prioritize tasks and meet deadlines in a dynamic manufacturing environment.
Ability to build and nurture positive relationships and work in a team environment with all levels of the organization.

Responsibilities

Ensure the site validation program is developed and maintained in compliance with regulatory and corporate requirements and Master Plans.
Represent Quality Assurance with qualification teams during requirements, design review, construction, qualification, documentation strategy, cleaning development and validation, and project implementation.
Review and approve C&Q documentation, including URS, IQ, OQ, and PQ protocols and reports, as well as SOPs, work instructions, and other technical documents.
Review and approve validation protocols and reports, including analytical, cleaning, and process validation documents.
Provide quality oversight for C&Q, CSV, and validation execution to ensure compliance with GMP, FDA, EMA, and other regulatory requirements.
Support development and implementation of C&Q and validation plans aligned with project timelines and deliverables.
Perform QA reviews of system impact assessments and equipment and utility categorizations.
Ensure compliance with company quality standards, SOPs, work instructions, and quality policies.
Serve as the QA point of contact for deviations, CAPAs, and change controls related to C&Q and validation activities.
Recommend process improvements to enhance compliance and efficiency in C&Q and validation activities.
Review and approve technology transfer documents to ensure they meet regulatory and J&J requirements.
Partner with other departments to implement compliance systems efficiently and support business, quality, and compliance goals under J&J standards.
Develop and implement processes, procedures, forms, work instructions, and tools for site compliance systems.
Administer site nonconformance management, change control, and training systems and their applicable Electronic Tracking System (ETS).
Support documentation review by evaluating and approving documents for regulatory submissions, SOPs, and quality management systems to ensure accuracy and compliance.
Collaborate with cross-functional teams, including engineering, validation, manufacturing, operations, engineering and maintenance, MSAT, and QC, to address quality issues.