Quality Assurance Area Specialist - SDF

Position: Quality Assurance Area Specialist I - SDF
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 the opportunity to help improve the quality of life for millions of people around the  NC, we operate three pharmaceutical manufacturing facilities that are responsible for fulfilling different steps in our injectable and oral treatment supply chains.

Our Emerging Technologies
-Solid Dosage Forms US facility in Durham, NC is a 194,000 square foot tableting and packaging facility that supports the production of our innovative oral treatments for patients with type 2 diabetes. SDF maintains a curious and pioneering spirit, harmonious with our growing pipeline of new products and emerging technologies.

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 Ensure Batch Production Records (BPRs) and/or relevant quality processes are compliant with regulations and/or relevant standard operating procedures (SOP's) and guidance. Accountable for 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.

Relationships Reports to Manager, QA.Essential Functions Ensure site compliance with Regulations, International Organization for Standardization (ISO) standards, corporate & local SOPsReview & approve documentation for Quality approval – batch records and other documentation

Support, review & approve investigations & root-cause analysis using LEAN tools and continuous improvement

Participate in process confirmations & Go Look Sees Evaluate trend & report data for Quality Management Reviews (QMRs) & Annual Product Review (APR) reports

Perform QA role to review and approve local production related Customer Complaint Investigations (escalate if necessary)
Participate in & support the audit management team as needed during internal, external audits and inspections

Responsible for training of AP and FP members responsible for conducting investigations

Follow all safety & environmental requirements in the performance of duties

This role is a 12 hour B shift position

Other duties as assigned

Physical 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 colour vision based on role. May require the ability to work in loud noise environments with hearing protections.

Qualifications Associate’s degree in life sciences or related field from an accredited college required.  Bachelor’s degree preferred

May consider a High School Diploma or GED with a minimum of six (6) years of experience in QA or related quality experience

Minimum of two (2) years QA and /or quality related, or API experience required, preferably in the pharmaceutical industry

Quality Experience…