QA Validation Area Specialist

About the Department

For almost 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.

In NC, we operate three pharmaceutical manufacturing facilities that are responsible for fulfilling different steps in our injectable and oral treatment supply chains.  Our newer Oral Finished Products (OFP) tableting facility in Durham, NC sits on 194,000 square feet of state-of-the-art equipment and supports the production of our innovative oral treatments for patients with type 2 diabetes.  Employees work across Bulk Production, Packaging, Warehouse, Business Support, QC and QA.  At OFP, you’ll join a global network of manufacturing professionals who are passionate about what they do and committed to helping us meet the growing demand for our treatments.  

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 – reimbursement up to $10,000 annually 
• 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.

Position Purpose

Responsible for review and/or approval of Deviations, Change Requests/SOPs, Training Material, Laboratory Investigations & Trend Reports; Supplier Program management; self-audits (in conjunction with LoB); QA presence & process confirmation on shop floor & improvement of quality processes:

• Train users & actively support IT systems which are used in collaboration with Corporate Quality Systems related to Document Management, Records Management, Change Control & Training Documentation/Support processes
• Support & implement improvement opportunities for the systems referenced above
• Support review and approve cross functional investigations and root cause analysis
• Support all Quality Management Systems (QMS) customer requests
• Train & support customers in Quality Systems owned by QMS department
• Coordinate & support business needs during audits & inspections
• Execute the document creation & revision process for various NN documentation in order to support Process Responsible, including processing SOPs, System Specifications, etc. & ownership of the electronic systems associated with documentation control
• Ensure local quality processes are in compliance with cross-functional requirements as well as regulatory requirements
• Ensure compliant execution & monitoring
• Drive corrective actions & quality improvement initiatives within production

Accountabilities

• Support incremental improvement of Quality Management Systems utilized at OFP Site Durham, such as Document Processing & Control, Records Management, Change Control, deviations, Audits & Inspections & Annual Product Review
• Implement improvements or systems identified in QMS that support departmental or customer needs
• Review & author QMS documentation, as required
• Coordinate corporate document reviews & communicate document changes (corporate & local) to site
• Control & organization of site records
• Support the site retrieval/archival needs during audits & inspections
• Support metrics for Quality System process improvements
• Provide coaching to QA Compliance & Site regarding quality-related activities
• Assist in plant-wide training on regulations, Quality systems & procedures
• Ensure site compliance with Regulations, ISO standards & corporate/local SOPs
• Review & approve change control requests
• Participate in project teams as the compliance resource
• Provide guidance to departments regarding quality-related activities
• Support, review & approve cross-functional investigations & root-cause analysis
• Participate in process confirmations & Go-Look-Sees
• Participate in knowledge & experience sharing with other QA team members to assure compliance with company procedures, policies & objectives
• Evaluate trend & report data for QMRs & APR reports
• Perform other duties as assigned
• Other accountabilities, as assigned

Required Qualifications

• BA/BS degree, preferably in a life science, engineering or related field
• Minimum of five (5) years of relevant work experience
• Knowledgeable in the following systems:  Document Management, Change Control, Deviations, Audits & Inspections & Records Management processes/databases
• Strong communication skills (verbal & written) & the ability to coach & train adult learners
• Knowledge of pharmaceutical manufacturing processes
• Strong attention to detail & excellent proofreading skills
• Strong computer skills necessary to learn & train others regarding IT systems associated with QMS responsibilities
• Willingness to learn new IT systems & develop progressive applications that improve processes & business

Desired Qualifications

Proven expertise in mentoring/development, change management, planning/organizing, managing execution & revising the work plan for complex problems solved by cross functional teams.

Physical & Other Requirements

• Occasionally moves equipment and/or supplies weighing up to 30 pounds within the facility
• Constantly operates a computer & other office equipment using hands
• Able to work in an open office environment with the possibility of frequent distraction
• Able to work the hours necessary to support a 24/7 continuous manufacturing operation
• Able to adjust schedule to work with colleagues in other international time zones

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.

Novo Nordisk requires all new hires to be fully vaccinated against COVID-19 prior to the first date of employment. As required by applicable law, Novo Nordisk will consider requests for reasonable accommodation.

If you are interested in applying to Novo Nordisk and need special assistance or an accommodation to apply, please call us at 1-855-411-5290. This contact is for accommodation requests only and cannot be used to inquire about the status of applications.