Senior Quality Assurance Area Specialist I (QA or IT & Automation)

BioSpace; Clayton (NC); On-site; USD 95,000 - 130,000; Full time

Benefits offered by this job

Leading pay and annual performance bon

Paid time off with 14 holidays

Health, Dental, Vision insurance from

8% 401K with company match

Parental & family medical leave

Product access program

Tuition assistance

Life & disability insurance

Employee referral awards

Job summary

Novo Nordisk operates its API fermentation and purification facilities in Clayton, NC, delivering quality products across injectable and oral therapies. This role supports validation, batch reviews, and QA on the shop floor, ensuring compliance and continuous improvement in a highly regulated manufacturing environment.

The position reports to the Quality Assurance manager and requires five+ years in pharma with strong cGMP knowledge, on-floor support, and cross-functional collaboration skills.

Qualifications

• Bachelor's degree in Life Sciences, Engineering, or related field.
• Minimum of five years in the pharmaceutical industry.
• Strong knowledge of cGMP manufacturing and production processes.
• Strong knowledge of Batch review processes.
• Strong knowledge of quality management systems.
• Strong knowledge of quality oversight and on-floor production support.
• Strong knowledge of cGMPs and validation.
• Strong knowledge in Quality Management Systems.
• Ability to work independently and meet deadlines.
• Ability to collaborate with customers and stakeholders.

Responsibilities

• Review batch reports and release API materials.
• Manage deviations and change controls.
• Review and approve SOPs with QA presence.
• Process confirmations and quality oversight on the shop floor.
• Improve quality processes and ensure regulatory compliance.
• Review and approve API/Intermediate batch documentation in systems like LIMs, SAP, NovoGlow.
• Ensure site compliance with regulations and ISO standards.
• Approve change controls and deviations.
• Provide guidance to departments on quality-related activities.
• Participate in root-cause analysis.

Skills

cGMP knowledge

Batch review

Quality systems

On-floor support

Validation knowledge

MS Office suite

Communication skills

Cross-functional work

Education

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

Tools

LIMs

SAP

NovoGlow

Job description

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.

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 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

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

Responsible for the production activities & validation. Ensures relevant compliance issues are addressed & handled in close collaboration with production. Main duties include review of batch reports & release of API materials, deviations, change controls, review & approval of SOPs, QA presence & process confirmation on shop floor & improvement of Quality processes.

Relationships

Reports to Manager, Quality Assurance.

Essential Functions

• Ensure that the current NN procedures & requirements from health authorities are reflected in the validation planning & quality related decisions
• Support validation projects in communicating Novo Nordisk project quality requirements & assessing suppliers’ ability to support test/qualification activities to ensure that Novo Nordisk requirements & expectations are clear
• Support projects in solving quality related issues, act quickly in order to come to a decision, & communicate quickly & clearly regarding such decisions
• Support evaluation of the quality level during the project by performing spot checks of validation documentation
• Perform activities related to Batch review & release
• Review & approve 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 change control requests
• Review & approve deviations
• 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

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

• Bachelor's Degree in Life Sciences, Engineering, or related field required
• Minimum of five (5) years of experience within the pharmaceutical industry required
• Good Knowledge of cGMP manufacturing & production processes & how to apply required
• Good Knowledge of the Batch review Processes required
• Good Knowledge of quality management systems required
• Good Knowledge of quality oversight & on floor production support required
• Strong knowledge level in cGMP's & validation required
• Strong knowledge in Quality Management Systems required
• Must be ability to perform tasks independently, accurately & within defined time frames required
• Ability to willingly work with customers/stakeholders in a cooperative manner required

Strong Written & Verbal Communication Skills Required

• Strong computer skills in MS Office, PowerPoint, Word, Excel, etc required
• Proven expertise in planning & organizing tasks preferred
• Willingness to assist others in developing plans in a cross-functional environment preferred
• Innovative approach to establishing priorities preferred

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

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.