QA Area Specialist I - SDF (2nd shift)

Novo Nordisk • Durham, NC

17h • 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

• Associate’s degree in life sciences or related field from an accredited college required.
• Minimum of two (2) years QA and /or quality related, or API experience required, preferably in the pharmaceutical industry
• Excellent written & verbal communication skills required
• Basic computer skills in MS Office, MS Project, PowerPoint, etc. required

Nice To Haves

• 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
• Quality Experience preferred
• General knowledge of pharmaceutical regulations & quality systems preferred
• Knowledge of Quality and one or more of the following: Aseptic Production, Business Support, QC, Production Support, Warehousing/Transport, API, and/or Finished Production processes preferred

Responsibilities

• 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.
• Ensure site compliance with Regulations, International Organization for Standardization (ISO) standards, corporate & local SOPs
• Review & 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
• Other duties as assigned

Benefits

• 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

What This Job Offers

• Job Type: Full-time
• Career Level: Entry Level
• Education Level: Associate degree