QA Area Specialist III - Finished Production (Validation Focus)

QA Area Specialist III - Finished Production (Validation Focus) Facility: Quality Location: Clayton, NC, US Position Overview 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. Essential Functions 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 Qualifications 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 Physical Requirements Moves equipment and/or supplies weighing up to 33 pounds within the facility using various body positions. Ability to do close precision work with hands. Must be able to remain in a stationary position (sitting and standing) 50% of the time. May require corrected vision of 20/20 or 20/25 based on role. May require color vision based on role. May require the ability to work in loud noise environments with hearing protections. Benefits Leading pay and annual performance bonus for all positions All employees enjoy generous paid time off including 14 paid holidays Health Insurance, Dental Insurance, Vision Insurance – effective day one Guaranteed 8% 401K contribution plus individual company match option Family Focused Benefits including 14weeks paid parental & 6 weeks paid family medical leave Free access to Novo Nordisk-marketed pharmaceutical products Tuition Assistance Life & Disability Insurance Employee Referral Awards EEO Statement We commit to an inclusive recruitment process and equality of opportunity for all our job applicants. Novo Nordisk is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to race, ethnicity, color, religion, sex, gender identity, sexual orientation, national origin, disability, protected veteran status or any other characteristic protected by local, state or federal laws, rules or regulations. Accommodation Request If you are interested in applying to Novo Nordisk and need special assistance or an accommodation to apply, please call us at View phone number on click.appcast.io. This contact is for accommodation requests only and cannot be used to inquire about the status of applications. #J-18808-Ljbffr