Quality Control Analyst II - SDF

BioSpace; Durham (NC); On-site; USD 60,000 - 90,000; Full time

Benefits offered by this job

Health Insurance

Dental Insurance

Vision Insurance

401K match

Paid holidays

Parental leave

Tuition Assistance

Life Insurance

Disability Insurance

Employee Referral Awards

Job summary

Novo Nordisk in Durham, NC is hiring a QC Analyst to perform and review analysis of in-process, release, and stability samples in line with cGMP and project plans. You will support tech transfer and ensure timely lab results.

The role emphasizes data integrity, deviation handling, and collaboration with the QC team to drive quality across product lines. Strong attention to detail is essential.

Qualifications

• Bachelor’s degree in Chemistry or related field required.
• Three years of experience in a clinical or industrial/pharmaceutical laboratory.
• Attention to detail is essential.
• Ability to author scientific or technical reports preferred.

Responsibilities

• Ensure accuracy and scientific soundness of lab data.
• Maintain GMP compliance of laboratory operations.
• Perform deviation investigations and change control activities.
• Coach and mentor other analysts.
• Data trending and tracking of results.
• Laboratory equipment validation and support.
• Laboratory IT system support.
• Follow safety and environmental requirements.

Skills

Lab data analysis

cGMP compliance

Coaching analysts

Data trending

Laboratory IT systems

Environmental safety

Education

Bachelor's degree in Chemistry or related field

Associate’s degree in chemistry with 3 years experience

Tools

HPLC

UPLC

Dissolution testing

SOP adherence

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

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 in accordance with cGMP, site & corporate procedures & policies. Transfer of technology & processes in accordance with relevant project plans & timelines.

Relationships

Reports to Senior Manager, QC – OFP.

Essential Functions

• Accuracy & Scientific Soundness of Lab Data
• Environmental Compliance
• GMP Compliance of Laboratory
• Maintain testing proficiency for methods
• Timeliness of Lab Results & Investigations
• Analysis of Samples
• Author Deviations
• Coaching other analysts
• Data Trending & Tracking
• Ensure departmental documents are current & standardized
• Laboratory Equipment Validation & System support
• Laboratory IT System support
• Perform deviation & change control activities
• Supports Deviations
• Systematic Problem Solving
• Follow all safety and 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 require 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

• Minimum of a Bachelor’s degree in Chemistry or relevant field of study from an accredited university required or an equivalent combination of education and experience
• May consider an Associate’s degree in chemistry or relevant field of study from an accredited university with a minimum of three (3) years of experience in a clinical or industrial/pharmaceutical laboratory
• May consider a High School Diploma or GED with a minimum of five (5) years of experience in a clinical or industrial/pharmaceutical laboratory
• Minimum of three (3) years of experience in a clinical or industrial/pharmaceutical laboratory required
• Must demonstrate attention to detail required

Preferred Qualifications

• Ability to author scientific & technical reports preferred
• Able to perform routine testing per SOP & GMP standards preferred
• Change control, deviation, trending a plus
• Knowledgeable in GMP & laboratory techniques preferred
• Serve as a subject matter expert on QC processes a plus
• Strong communication skills (verbal & written) preferred
• Troubleshooting for laboratory equipment a plus
• Validation & technical transfer experience a plus
• Skills or knowledge in the following discipline: Chemistry Analysis of tablets including UPLC and Dissolution 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.