Quality Assurance Area Specialist III
2 weeks ago
About the Department
At Novo Nordisk, we want to make a difference. For more than 100 years, we have led the way in diabetes care. Being part of Novo Nordisk allows our employees to embark on life-changing careers, and the opportunity to help improve the quality of life for millions of people around the world.
In NC, we operate three pharmaceutical manufacturing facilities that are responsible for fulfilling different steps in our injectable and oral treatment supply chains. Our legacy Injectable Finished Products (IFP) facility in Clayton, NC is a 457,000 square foot aseptic "fill and finish" site that is responsible for producing innovative, injectable diabetes and obesity treatments. At IFP, you'll join a global network of manufacturing professionals who are passionate about what they do.
What we offer you:
Leading pay and annual performance bonus for all positionsAll employees enjoy generous paid time off including 14 paid holidaysHealth Insurance, Dental Insurance, Vision Insurance – effective day oneGuaranteed 8% 401K contribution plus individual company match optionFamily Focused Benefits including 12 weeks paid parental & 6 weeks paid family medical leaveFree access to Novo Nordisk-marketed pharmaceutical productsTuition AssistanceLife & Disability InsuranceEmployee 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 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 Senior Manager, Quality Assurance. Essential FunctionsMake decisions on quality & compliance issues with little guidanceParticipate in process group activities as assigned & leads local implementationsEnsure site compliance with Regulations, ISOISP standards, corporate & local standard operating procedures (SOPs)Lead improvement activities/improvement of standards within the assigned processReview & approves change control documentation, SOPs & other current good manufacturing practice (cGMP) documentationProvide coaching to Site regarding quality & compliance related activitiesSupports, reviews & approves complex cross-functional investigations & root-cause analysisFacilitates sharing of regulatory & compliance expectationsReviews & approves complex DVs, CRs, (SOPs), trend & report data for CAPA, Quality Management Reviews (QMRs) & Annual Product Review (APR) reportsEliminates non-value-added practicesFollow all safety & environmental requirements in the performance of dutiesOther 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. QualificationsHigh School Diploma or equivalent (GED) requiredBachelor'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 requiredMinimum 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 requiredDemonstrated 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 preferredQuality Risk Management experience requiredExperience with regulatory requirements computer system, such as 21 CFR Part 11, GAMP5, ISO, Data Integrity requiredExperience in use of Risk Assessment & Vendor Assessments during evaluation of change controls, deviation and validation activities requiredExpert 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 preferredExcellent troubleshooting skills; able to identify root cause of problem requiredDemonstrated knowledge of critical controls & input/output requirements for processes in these areas: semi-finished manufacturing, finished manufacturing QC, IT & process utilities preferredExcellent written & verbal communication skills requiredAuditing experience with certification preferred (internal/external) requiredExperience with LEAN, Six Sigma & other continuous improvement methodologies requiredExpert competence in one or more core validation areas (sterilization, packaging, cleaning, utilities, process or computer validation) preferredKnowledge of statistical methods (hypothesis testing, sampling, trending, CpK, etc.) requiredExpert in utilizing appropriate root-cause analysis tools & techniques preferredExperience with Risk Assessment & Risk Management requiredDemonstrated excellence with time management, organizational & project management skills requiredExpertise in planning/organizing, checking results & revising the work plan for complex problems being resolved by cross functional teams 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.
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