Quality Assurance Area Specialist III - QA IT / QC

About the Department Fill & Finish Expansions (FFEx) is responsible for all major expansion activities within aseptic production, solid dosage forms, finished products, fill & finish warehousing, and QC across all production areas in Product Supply. FFEx designs, plans, and builds new aseptic filling capacity across Novo Nordisk to serve patients worldwide. What We Offer You Leading pay and annual performance bonus for all positions Generous paid time off including 14 paid holidays Health, dental, and vision insurance effective day one Guaranteed 8% 401(k) contribution plus individual company match option Family focused benefits including 14 weeks paid parental leave and 6 weeks paid family medical leave Free access to Novo Nordisk‑marketed pharmaceutical products Tuition assistance Life & disability insurance Employee referral awards The Position Ensures plant systems batch release and/or relevant quality processes are compliant with regulations. Holds product release authority when applicable. Provides quality oversight, review and approval of validation activities and documents associated with projects, new systems, changes to existing systems, and maintains validated state of equipment, processes, and systems. Presents, supports and coaches for audits and inspections. Reviews and approves complex Change Requests, Deviations, CAPAs, and other documentation. Performs self‑audits in conjunction with line of business; provides QA presence and process confirmation on the shop floor. Relationships Reports to Senior Manager, Quality Assurance. Essential Functions Make decisions on quality and compliance issues with minimal guidance Participate in and lead local implementations of process group activities Ensure site compliance with regulations, ISO/TS standards, corporate and local SOPs Lead improvement activities and enhance standards within the assigned process Review and approve change control documentation, SOPs and other cGMP documents Coaching to site regarding quality and compliance related activities Support complex cross‑functional investigations and root‑cause analysis Facilitate sharing of regulatory and compliance expectations Approve complex deviations, change requests, and trend & report data for CAPA, QMRs, and APRs Eliminate non‑value‑added practices Follow all safety and environmental requirements in the performance of duties Other accountabilities as assigned Physical Requirements Moves equipment or supplies weighing up to 33 pounds. Performs close precision work with hands. Remains in a stationary position (sitting and standing) 50% of the time. Corrected vision to 20/20 or 20/25 may be required. Color vision may be required. Ability to work in loud noise environments with hearing protection is required. 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 a AQP) Minimum of seven (7) years of QA and/or related quality experience in manufacturing, utility and/or packaging systems, preferably in the pharmaceutical or medical device field Demonstrated expertise in Regulations & quality systems in areas such as product disposition, DV/CAPA, Change Control, Audits, Supplier Management, Project Management, Validation, laboratory method and equipment validation, warehouse/logistics, and IT preferred Quality Risk Management experience required Experience with regulatory requirements such as 21 CFR Part 11, GAMP5, ISO, Data Integrity required Experience using Risk Assessment & Vendor Assessments during change controls, deviation and validation activities required Expertise in cGMP documentation practices and reviewing GMP documents for compliance required Excellent troubleshooting and root‑cause analysis skills required Knowledge of critical controls & input/output requirements for processes such as semi‑finished manufacturing, finished manufacturing QC, IT & process utilities preferred Excellent written and verbal communication skills required Auditing experience with internal/external certification preferred Experience with LEAN, Six Sigma & other continuous improvement methodologies required Expert competence in core validation areas (sterilization, packaging, cleaning, utilities, process or computer validation) preferred Knowledge of statistical methods (hypothesis testing, sampling, trending, CpK, etc.) required Expertise in utilizing root‑cause analysis tools & techniques preferred Experience with Risk Assessment & Risk Management required Demonstrated excellence in time management, organizational & project management skills required Equal Opportunity Employer We commit to an inclusive recruitment process and equality of opportunity for all 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. #J-18808-Ljbffr BioSpace