Quality Control Analyst III

Initial Therapeutics, Inc.; Durham (NC); On-site; USD 65,000 - 110,000; Full time

Benefits offered by this job

Leading pay and performance bonus

14 paid holidays

Health Insurance

Dental Insurance

Vision Insurance

8% 401K with company match

Parental & family leave

Free product access

Tuition Assistance

Life & Disability Insurance

Employee Referral Awards

Job summary

Novo Nordisk seeks a Laboratory Analyst in Durham, NC to perform and review in-process, release and stability sample analyses for API and filled product, ensuring data accuracy and GMP compliance. You will lead peers, transfer technologies per project plans, and uphold safety standards in a fast-paced environment.

The role requires strong lab technique knowledge, report writing skills, and the ability to support deviations and system validations.

Qualifications

• Bachelor’s degree required.
• Associate’s degree with seven years of relevant lab experience considered.
• Five years of experience in a clinical or industrial/pharmaceutical lab required.
• Ability to author scientific/technical reports and SOPs.
• Advance level GMP knowledge and lab techniques required.
• Strong attention to detail and clear communication.

Responsibilities

• Ensure accuracy and scientific soundness of lab data.
• Maintain GMP laboratory compliance and environmental safety.
• Perform analyses of samples and deviations.
• Coach other analysts and drive data trending and investigations.
• Prepare and review laboratory documents and validation support.

Skills

Lab data analysis

GMP knowledge

Coaching & mentoring

Analytical thinking

Education

Bachelor's degree

Associate’s degree + 7 years experience

Tools

HPLC

UPLC

GC

TOC

UV

KF

Isolator

Sterility testing

Endotoxin testing

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.

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 USfacility 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

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

Perform & review analysis of in-process, release & stability samples of API and/or filled product in accordance with cGMP, site & corporate policies & procedures. Transfer of technology & processes in accordance with relevant project plans & timelines. Provide leadership for other analysts as they execute their daily tasks.

Relationships

Reports to Manager.

Essential Functions

• Ensure accuracy & scientific soundness of lab data
• Endure environnemental compliance
• Support & ensure GMP Laboratory Compliance
• Maintain testing proficiency for methods
• Ensure timeliness of lab results & investigations
• Perform analysis of samples
• Author deviations
• Coach other analysts
• Perform data trending & tracking
• Develop process competence across IFP/APID
• Drive process improvement for Site QC
• Ensure all Analyst testing of samples is complete, as needed
• Ensure departmental documents are current & standardized
• Perform Laboratory Equipment Validation & System support
• Provide Laboratory IT System support
• Leverage solutions to other NNPILP sites
• Perform deviation & change control activities
• Support other NNPILP sites when relevant
• Support deviations
• Participate in Systematic Problem Solving
• Follow all safety & environmental requirements in the performance of duties
• 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.

Minimum Qualifications

• Bachelor’s Degree from an accredited university required
• May consider an Associate’s Degree from an accredited university with seven (7) years of relevant experience in a clinical or industrial/pharmaceutical laboratory required
• Five (5) years of experience in a clinical or industrial/pharmaceutical laboratory required
• Ability to author scientific & technical reports required
• Able to perform routine testing per SOP & GMP standards required
• Advance level knowledge in GMP & laboratory techniques required
• Demonstrate attention to detail required
• Serve as a subject matter expert on QC processes required
• Strong communication skills (verbal & written) required
• Skills or knowledge in one of the following disciplines: Chemistry Analysis (HPLC, UPLC, GC, TOC, AA, UV, PH, KF), Microbiology Analysis (Isolator, Sterility, Bacterial Endotoxin testing, Growth Promotion and Microbial Identification, ELISA, BIOBURDEN) or Raw Materials Analysis (Compendial Testing, FTIR, NIR, Titration and UV-Vis) required

Preferred Qualifications

• Advanced level of troubleshooting for laboratory equipment preferred
• Validation & technical transfer experience preferred
• Project Management experience is a plus
• Change control, deviation, trending preferred

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.