QA Area Specialist II - SDF (3rd shift)

Novo Nordisk•Durham, NC

9d•Onsite

About The Position

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 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 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.

Requirements

Bachelor’s degree in life sciences or related field of study from an accredited university required
May 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 experience
May consider a High School Diploma or GED with a minimum of seven (7) years of experience in QA or related quality experience
Minimum of three (3) years of QA &/or quality related or API experience required, preferably in the pharmaceutical industry
Understanding of cGMP manufacturing & production processes & how to apply required
Understanding of the Batch Review Processes required
Understanding of quality management systems required
Understanding of quality oversight & on floor production support required
Knowledge in Quality Management Systems required
Excellent written & verbal communication skills required
Basic computer skills in MS Office, MS Project, PowerPoint, etc. Required

Nice To Haves

Understanding of validation preferred
Demonstrated knowledge of critical controls & input/output requirements for NNPILP processes preferred
Auditing experience with certification a plus
Experience in the use of Six Sigma & LEAN tools a plus

Responsibilities

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.
Ensure site compliance with Regulations, International Organization for Standardization (ISO) standards, corporate & local SOPs
Review & approve documentation for Quality approval – components/raw material, batch records, change control requests, deviations & validation documents
Perform QA presence & process confirmation on shop floor
Participate in project teams as a quality resource
Support, review & approve investigations & root-cause analysis
Participate in process confirmations & Go Look Sees
Evaluate trend & report data for QMRs & APR reports
Follow all safety & environmental requirements in the performance of duties
Other duties as assigned