About the Department
For more than 100 years, Novo Nordisk has been tackling the unmet medical needs of people living with serious chronic diseases, such as diabetes & obesity. 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.
Our new Petersburg, Virginia site marks a strategic move to advance our capabilities in Emerging Technologies (ET) within Chemical API development and production. The highly experienced site is designed to strengthen and accelerate our Small Molecule (SMOL) strategy while amplifying our operational capacity. This is to safeguard and support ET's SMOL projects in the coming years, aligning with our vision and strengthening our potential for growth and innovation.
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
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
Perform quality review & approval of Batch Production Records (BPRs), Change Requests (CR's), Deviations & other documentation (in conjunction with LoB) & QA presence & process confirmation on shop floor. Handle release of raw materials & provides quality oversight, review & approval of validation activities associated with minor changes to existing systems. Perform archiving duties & QA presence & process confirmation on shop floor.
Relationships
Sr 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 & validation documentsPerform QA presence & process confirmation on shop floorParticipate in project teams as a quality resourceSupport, review & approve investigations & root-cause analysisParticipate in process confirmations & Go Look SeesEvaluate trend & report data for QMRs & APR reportsFollow all safety & environmental requirements in the performance of dutiesOther duties as assignedPhysical Requirements
May move equipment &/or supplies weighing up to 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.
Qualifications
Bachelor's degree in life sciences or related field of study from an accredited university requiredMay consider an associate's degree in life sciences or related field from an accredited college with a minimum of five (5) years of experience in QA or related quality experienceMay consider a High School Diploma or GED with a minimum of seven (7) years of experience in QA or related quality experienceMinimum of three (3) years of QA &/or quality related or API experience required, preferably in the pharmaceutical industryUnderstanding of cGMP manufacturing & production processes & how to apply requiredUnderstanding of the Batch Review Processes requiredUnderstanding of validation preferredUnderstanding of quality management systems requiredUnderstanding of quality oversight & on floor production support requiredKnowledge in Quality Management Systems requiredDemonstrated knowledge of critical controls & input/output requirements for NNPILP processes preferredExcellent written & verbal communication skills requiredBasic computer skills in MS Office, MS Project, PowerPoint, etc. requiredAuditing experience with certification a plusExperience in the use of Six Sigma & LEAN tools a plusWe 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 1-. This contact is for accommodation requests only and cannot be used to inquire about the status of applications.