Quality Assurance Area Specialist II - OFP 2nd Shift ( Release Focus)

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.

 

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 - Oral Finished Products 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. OFP 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 12 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

Performs 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. Handles release of raw materials & provides quality oversight, review & approval of validation activities associated with minor changes to existing systems. Performs archiving duties & QA presence & process confirmation on shop floor.

 

Relationships

Manager, Quality Assurance.

 

Essential Functions

• Ensures site compliance with Regulations, ISO standards, corporate & local SOPs
• Reviews & approves documentation for Quality approval – components/raw material, batch records, change control requests, deviations & validation documents
• Performs QA presence & process confirmation on shop floor
• Participates in project teams as a quality resource
• Supports, reviews & approves investigations & root-cause analysis
• Participates in process confirmations & Go Look Sees
• Evaluates trend & report data for QMRs & APR reports
• Other accountabilities, as assigned.

 

Physical Requirements

Occasionally moves equipment &/or supplies weighing up to 33 pounds. Ability to work in an open office environment with the possibility of frequent distraction. Ability to work the hours necessary to support a 24/7 continuous manufacturing operation. Ability to adjust schedule to work with colleagues in other international time zones. Some roles require ability to work 12-hour shifts or longer, day or night. Ability to travel domestically &/or internationally, as necessary.

 

Qualifications

• Bachelor’s degree in life sciences or related field of study from an accredited university required
• With P&O review/agreement, equivalent combination of education & internal NN business/operational experience may be substituted for degree as appropriate
• Minimum of three (3) years of QA &/or quality related experience required, preferably in the pharmaceutical or medical device industry
• Understanding of cGMP manufacturing & production processes & how to apply required
• Understanding of the Batch Review Processes required
• Understanding of validation preferred
• Understanding of quality management systems required
• Understanding of quality oversight & on floor production support required
• Knowledge in Quality Management Systems
• Demonstrated knowledge of critical controls & input/output requirements for NNPILP processes preferred
• Excellent written & verbal communication skills required
• Basic computer skills in MS Office, MS Project, PowerPoint, etc. required
• Auditing experience with certification a plus
• Experience in the use of Six Sigma & LEAN tools a plus
• Personal Time Management: Sets goals & prioritizes tasks for own work on short-term basis
• Meets deadlines & makes regular progress re