QA Area Specialist III - Finished Production; Validation Focus

QA Area Specialist III - Finished Production (Validation Focus)

Facility:
Quality

Location:

Clayton, NC, US

This role supports our Finished Production area with a focus on review of validation activities. It ensures plant systems batch release, and/or relevant quality processes are compliant with regulations. The position may have product release authority if it is in batch release. Responsibilities include quality oversight, review and approval of validation activities and documents associated with projects, new systems, changes to existing systems, and maintaining a validated state of equipment, processes, and systems.

It also involves presentation, support, and coaching for audits and inspections, review and approval of complex change requests (CRs), deviations (DVs), CAPAs, and other documentation. The role performs self audits in conjunction with line of business, provides QA presence and process confirmation on the shop floor, and acts as site Clayton Process Representative as assigned. The incumbent supports all processes and functions in the Department, trends and reports data as applicable, and works in an onsite, Monday‑Friday environment.

• Make decisions on quality & compliance issues with little guidance
• Participate in process group activities as assigned and lead local implementations
• Ensure site compliance with regulations, ISOISPs, corporate and local SOPs
• Lead improvement activities and improvement of standards within the assigned process
• Review and approve change control documentation, SOPs and other cGMP documentation
• Provide coaching to the site regarding quality & compliance related activities
• Support, review and approve complex cross‑functional investigations and root‑cause analyses
• Facilitate sharing of regulatory & compliance expectations
• Review and approve complex DVs, CRs, SOPs, trend & report data for CAPA, Quality Management Reviews (QMRs), and Annual Product Review (APR) reports
• Eliminate non‑value‑added practices
• Follow all safety & environmental requirements in the performance of duties
• Other accountabilities as assigned

• High School Diploma or equivalent (GED) required
• Bachelor’s degree in Life Sciences or a relevant field from an accredited university preferred; required if hired as an AQP
• Minimum of seven (7) years of QA and/or related quality experience in manufacturing, utility and/or packaging systems, preferably in pharmaceuticals or medical devices
• Demonstrated expertise in regulations & quality systems in one or more of the following: product disposition, DV/CAPA, Change Control, Audits, Supplier Management, Project Management, Validation, laboratory method and equipment validation, warehouse/logistics, and IT
• Quality Risk Management experience required
• Experience with regulatory requirements such as 21 CFR Part 11, GAMP5, ISO, Data Integrity required
• Experience in use of risk assessment & vendor assessments during evaluation of change controls, deviation and validation activities required
• Expertise in cGMP documentation practices; minimum four (4) years of reviewing GMP documents for compliance for approval of quality documentation preferred
• Excellent troubleshooting skills; able to identify root cause of problems required
• Knowledge of critical controls & input/output requirements for semi‑finished manufacturing, finished manufacturing QC, IT & process utilities preferred
• Auditing experience with certification preferred (internal/external) required
• Experience with LEAN, Six Sigma & other continuous improvement methodologies required
• Expert competence in one or more core validation areas (sterilization, packaging, cleaning, utilities, process or computer validation) preferred
• Knowledge of statistical methods (hypothesis testing, sampling, trending, CpK, etc.) required
• Expertise using root‑cause analysis tools & techniques preferred
• Experience with risk assessment & risk management required
• Demonstrated excellence with time management, organization & project management skills required

Moves equipment and/or supplies weighing up to 33 pounds within the facility using various body positions. Ability to do close…