QA Area Specialist I - SDF (2nd shift)

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. 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 innovative oral treatments for patients with type 2 diabetes. The team maintains a curious and pioneering spirit, harmonious with our growing pipeline of new products and emerging technologies.

About the role

Ensure Batch Production Records (BPRs) and/or relevant quality processes are compliant with regulations and/or relevant standard operating procedures (SOPs) and guidance. Accountable for Quality review & approval of Change Requests (CRs), Deviations & other documentation. Perform Self Audits (in conjunction with line of business (LoB)), Quality Assurance (QA) presence & process confirmation on the shop floor.

Responsibilities

• 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

Requirements

• 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
• 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
• Excellent written & verbal communication skills required
• Basic computer skills in MS Office, MS Project, PowerPoint, etc. required

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 require corrected vision to 20/20 or 20/25 based on role
• May require color vision based on role
• May require the ability to work in loud noise environments with hearing protections

Benefits

• Leading pay and annual performance bonus for all positions
• 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
• 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

Reports to Manager, Quality Assurance.