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Quality Assurance Area Specialist II/III
4 months ago
About the Department
You will be joining Fill & Finish Expansions (FFEx), which 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. The area is anchored in Product Supply, Quality & IT, which globally employ approx. 20,000 of Novo Nordisk's 50,000 employees.
FFEx is a newly established and growing area with the responsibility to design, plan, and build all new aseptic filling capacity across Novo Nordisk to serve the needs of millions of patients. We do it by rethinking our production facilities with the use of modern technology, as we are setting the standards for the aseptic production of the future. Facilities designed today which we will still be proud of 20 years from now. FF Expansions has a global approach, where you will be working with multiple sites and cultures across the world.
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 12 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
At Novo Nordisk, you will find opportunities, resources, and mentorship to help grow and build your career. Are you ready to realize your potential? Join Team Novo Nordisk and help us make what matters.
The Position
Ensure Batch Production Records (BPRs) & relevant quality processes are compliant with regulations and associated corporate and local standard operating procedures (SOPs)Release of raw materials. Quality oversight, review & approval of validation activities associated with minor changes to existing systems. Review periodic system evaluations for maintaining validated state. Quality review & approval of Change Requests (CR's), Deviations & other documentation. Perform Self Audits (in conjunction with line of business (LoB)), Quality Assurance (QA) presence & process confirmation on shop floor with stakeholder.
Relationships
Senior Manager, Quality Assurance.
Essential Functions
Ensure site compliance with Regulations, International Organization for Standardization (ISO) standards, corporate & local SOPsReview & approve documentation for Quality approval – components/raw material, batch records, change control requests, deviations, , Quality Control (QC) laboratory investigations, SOPs & validation documentsParticipate in project teams as a quality resourceSupport, review & approve investigations & root-cause analysis using LEAN tools and continuous improvement techniquesParticipate in process confirmations & Go Look SeesEvaluate trend & report data for Quality Management Reviews (QMRs) & Annual Product Review (APR) reportsFollow all safety & environmental requirements in the performance of dutiesOther accountabilities, as assigned Physical Requirements May move equipment &/or supplies weighing up to thirty-three (33) pounds within the facility using various body positions. May be required to be on your feet for up to a 12-hour shift. 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. QualificationsHigh School Diploma (GED) requiredBachelor's degree in Life Sciences or a relevant field of study from an accredited university preferredMinimum of four (4) years of QA and/or quality related experience in the pharmaceutical or medical device industry with progressively increasing responsibility requiredGeneral knowledge of regulations & quality systems (e.g., product disposition, deviations, Change Control, Audits, Supplier Management, Project Management, etc.) preferredFamiliarity with local processes & quality systems preferredFamiliarity with risk assessment/risk management preferredDemonstrated knowledge of critical controls & input/output requirements for NNPILP processes preferredKnowledge of Quality, and /or Aseptic Production, Business Support, QC, IT, Facilities/Utilities, warehousing/logistics, O&P, and Finished Production processes preferredKnowledge of US, EU regulations & guidelines, ISO standards & application of Good Manufacturing Practices (GMPs) preferredExcellent written & verbal communication skills requiredBasic computer skills in MS Office, MS Project, PowerPoint, etc. requiredAuditing experience with certification requiredExperience in the use of Six Sigma & LEAN tools requiredSets goals & prioritizes tasks for own work on short-term basis requiredMeets deadlines & makes regular progress reports on performance requiredKeeps track & informs management about fluctuation in workload requiredPerforms well with multi-tasking requiredAdjust priorities in accordance with changing circumstances required We commit to an inclusive recruitment process and equality of opportunity for all our job applicants. At Novo Nordisk we recognize that it is no longer good enough to aspire to be the best company in the world. We need to aspire to be the best company for the world and we know that this is only possible with talented employees with diverse perspectives, backgrounds and cultures. We are therefore committed to creating an inclusive culture that celebrates the diversity of our employees, the patients we serve and communities we operate in. Together, we're life changing. 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. If you are interested in applying to Novo Nordisk and need special assistance or an accommodation to apply, please call us at This contact is for accommodation requests only and cannot be used to inquire about the status of applications.