Quality Assurance Area Specialist II - API

Novo Nordisk A/S; Clayton (NC); On-site; USD 90,000 - 120,000; Full time

Benefits offered by this job

Annual bonus

Paid holidays

Healthy insurance

401K match

Parental leave

Tuition assistance

Life & disability insurance

Employee referrals

Job summary

Novo Nordisk in Clayton, NC is seeking a Quality Assurance Area Specialist II - API to review API batch reports, oversee minor changes and deviations, and drive quality processes on the shop floor. You will collaborate with QA to ensure GMP compliance and support continuous improvement in an API manufacturing setting.

The role requires a life sciences or engineering background and at least 3 years in QA within pharma, with strong knowledge of batch review and quality systems.

Qualifications

• Bachelor's degree or equivalent combination of education and work experience.
• 3+ years of QA or related experience in pharma/medical devices preferred.
• Understanding of cGMP manufacturing and production processes.
• Understanding of Batch review processes, quality oversight, and production support.
• Understanding of quality management systems and GMP regulations.
• Good stakeholder relations and workload prioritization.

Responsibilities

• Perform batch review activities for API materials release.
• Review API/Intermediate batch documentation in LIMs, SAP, NovoGlow, etc.
• Ensure site compliance with regulations, ISO standards, and SOPs.
• Review and approve minor change controls and low complex major changes.
• Review and approve minor deviations and low complexity major deviations.
• Provide guidance to departments on quality activities.
• Participate in root-cause analysis and process confirmations.
• Contribute to quality oversight on the shop floor.
• Act as an Authorized person per Novo Nordisk Quality Manual.
• Handle other accountabilities as assigned.

Skills

cGMP manufacturing

Batch review processes

Quality management systems

Quality oversight

Quality and production processes

Stakeholder relations

Prioritizing & workload management

Education

Bachelor's Degree in Life Sciences/Engineering or related field

3+ years QA or related experience

Job description

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Quality Assurance Area Specialist II - API

Facility: Quality

Location: Clayton, NC, US

About the Department

At Novo Nordisk, we are helping to improve the quality of life for millions of people worldwide. For more than 100 years, we have led the way in diabetes care. 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 newer Active Pharmaceutical Ingredients (API) facility in Clayton, NC sits on 825,000 square-feet of state-of-the-art equipment, and houses the Fermentation, Recovery and Purification in the production of ingredients for Novo Nordisk’s innovative oral products. At API, you’ll join a global network of manufacturing professionals who are passionate about what they do.

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 14weeks 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

Main duties include review of batch reports for release of API materials, minor deviations, minor change controls, review & approval of SOPs, QA presence & process confirmation on shop floor & improvement of Quality processes.

Relationships

Reports to Manager, QA.

Essential Functions

• Perform activities related to Batch review
• Review API/Intermediate Batch documentation in various Novo Nordisk systems (e.g., LIMs, SAP, NovoGlow, etc.)
• Ensure site compliance with Regulations, ISO standards, & Corporate/Local SOPs
• Review & approve minor change control requests & low complex major change controls
• Review & approve minor deviations & low complexity major deviations
• Provide guidance to departments regarding quality & related activities
• Participate & provide input to root-cause analysis
• Participate in process confirmations & quality oversight
• Authorized person according to Novo Nordisk Quality Manual
• Other accountabilities, as assigned

Physical Requirements

Moves equipment &/or supplies weighing up to 33 pounds within the facility using various body positions. Ability to do close precision work with their hands. Must be able to remain in a stationary position (sitting and standing) 50% of the time. May required corrected vision to 20/25 based on role. May require colour vision based on role. Occasionally ascends/descends a ladder. May be required to work at elevated heights. Occasionally works around odorous &/or hazardous materials.

Qualifications

• Bachelor's Degree in Life Sciences, Engineering, or related field or equivalent combination of education & work experience required
• Minimum of three (3) years of QA or related experience in the pharmaceutical or medical device industry preferred
• Understanding of cGMP manufacturing & production processes & how to apply required
• Understanding of the Batch review Processes preferred
• Understanding of quality management systems preferred
• Understanding of quality oversight & on floor production support preferred
• Understanding of cGMPs in pharmaceutical manufacturing required
• Understanding of Quality & Production processes required
• Good stakeholder relations required
• Capable of prioritizing & managing workload 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.