Quality Assurance Area Specialist I - SDF

BioSpace; Durham (NC); On-site; USD 75,000 - 110,000; Full time

Benefits offered by this job

Annual bonus

Paid holidays

Health insurance

401K with match

Parental leave

Tuition assistance

Life & disability insurance

Referral program

Job summary

Novo Nordisk in Durham, NC is seeking a QA professional to ensure batch records and related quality processes meet SOPs and regulatory standards. You will review documentation, support investigations, and participate in audits to drive continuous improvement.

The role requires QA experience in pharma, understanding of ISO regulations, and strong written communications. It is a 12-hour B shift with comprehensive benefits and growth opportunities within a global healthcare leader.

Qualifications

• Associate’s degree in life sciences; Bachelor’s preferred.
• Minimum of two years QA experience in pharmaceutical quality.
• High school diploma with six years QA experience considered.

Responsibilities

• Ensure site compliance with regulations, ISO standards and SOPs.
• Review/approve documentation for QA and batch records.
• Support investigations and root-cause analysis using LEAN tools.
• Participate in process confirmations and Go Look Sees.
• Evaluate trends for QMRs and APR reports.
• Review/approve customer complaint investigations as needed.
• Support internal/external audits and inspections.
• Train AP/FP staff responsible for investigations.
• Follow safety and environmental requirements in duties.
• This role is a 12-hour B shift position.
• Other duties as assigned.

Skills

QA experience

LEAN tools

Documentation review

MS Office

Education

Associate’s degree in life sciences

Bachelor’s degree preferred

Tools

MS Office

MS Project

PowerPoint

Job description

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 world.

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 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.

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

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 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
• 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 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

Excellent Written & Verbal Communication Skills Required

• Basic computer skills in MS Office, MS Project, PowerPoint, etc. required

We commit to an inclusive recruitment process and equality of opportunity for all our job applicants.

At Novo Nordisk, we're not chasing quick fixes – we're creating lasting change for long-term health. For over 100 years, we've been driven by a single purpose: to defeat serious chronic diseases and help millions of people live healthier lives. This dedication fuels our constant curiosity and inspires us to push the boundaries of what's possible in healthcare. We embrace diverse perspectives, seek out bold ideas, and build partnerships rooted in shared purpose. Together, we're making healthcare more accessible, treating and defeating diseases, and pioneering solutions that create change spanning generations. When you join us, you become part of something bigger – a legacy of impact that reaches far beyond today.

Novo Nordisk is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to race, ethnicity, color, religion, sex, gender identity, sexual orientation, national origin, disability, protected veteran status or any other characteristic protected by local, state or federal laws, rules or regulations.

If you are interested in applying to Novo Nordisk and need special assistance or an accommodation to apply, please call us at 1-855-411-5290. This contact is for accommodation requests only and cannot be used to inquire about the status of applications.