Quality Assurance Area Specialist III - QA IT / Utilities

What we offer you 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 14 weeks paid parental & 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. Has product release authority if role is in batch release. Quality oversight, review & approval of validation activities and documents associated with projects, new systems, changes to existing systems & maintaining validated state of equipment, processes, and systems. Presentation, support & coaching for audits & inspections. Review & approval of complex Change Requests (CR's), Deviations (DVs), CAPAs & other documentation. Performs Self Audits (in conjunction with line of business (LoB)); Quality Assurance (QA) presence & process confirmation on shop floor. Site Clayton Process Representative as assigned. Able to support all processes & functions in Department. Trends and reports data as applicable. Relationships Reports to Senior Manager, Quality Assurance. Essential Functions Make decisions on quality & compliance issues with little guidance Participate in process group activities as assigned & leads local implementations Ensure site compliance with Regulations, ISOISP standards, corporate & local standard operating procedures (SOPs) Lead improvement activities/improvement of standards within the assigned process Review & approves change control documentation, SOPs & other current good manufacturing practice (cGMP) documentation Provide coaching to Site regarding quality & compliance related activities Supports, reviews & approves complex cross-functional investigations & root-cause analysis Facilitates sharing of regulatory & compliance expectations Reviews & approves complex DVs, CRs, (SOPs), trend & report data for CAPA, Quality Management Reviews (QMRs) & Annual Product Review (APR) reports Eliminates non-value-added practices Follow all safety & environmental requirements in the performance of duties Other accountabilities, as assigned Physical Requirements Moves equipment &/or supplies weighing up to 33 pounds within the facility using various body positions. Ability to do close precision work with their hands. Must be able to remain in a stationary position (sitting and standing) 50% of the time. May required corrected vision to 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. Qualifications High School Diploma or equivalent (GED) required Bachelor’s degree in Life Sciences or a relevant field of study from an accredited university preferred. ***If hired as a AQP, Bachelor’s degree in Life Sciences or a relevant field of study from an accredited university required 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 required 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 preferred Quality Risk Management experience required Experience with regulatory requirements computer system, 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 Expert in cGMP documentation practices. Requires a minimum of four (4) years of experience in reviewing GMP documents for compliance purposes for approval of quality documentation preferred Excellent troubleshooting skills; able to identify root cause of problem required Demonstrated knowledge of critical controls & input/output requirements for processes in these areas: semi-finished manufacturing, finished manufacturing QC, IT & process utilities preferred Excellent written & verbal communication skills required 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 Expert in utilizing appropriate root-cause analysis tools & techniques preferred Experience with Risk Assessment & Risk Management required Demonstrated excellence with time management, organizational & project management skills required 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. #J-18808-Ljbffr Novo Nordisk