Quality Control Analyst II - SDF (Durham, NC, US)

Biopharma Careers; North Carolina; On-site; USD 55,000 - 75,000; Full time

Benefits offered by this job

Leading pay and annual performance-bon

14 paid holidays

Health Insurance

Dental Insurance

Vision Insurance – effective day one

401K with company match

Parental & family medical leave

Tuition Assistance

Life & Disability Insurance

Employee Referral Awards

Job summary

Novo Nordisk is hiring for a QC Analyst position in North Carolina. The role focuses on performing and reviewing analysis of in-process, release, and stability samples in line with cGMP and site procedures.

You will transfer technology and processes per project plans and timelines, reporting to the Senior Manager, QC – OFP. The ideal candidate holds a chemistry degree with relevant lab experience, demonstrates meticulous attention to detail, and is capable of coaching other analysts while

Qualifications

• Bachelor’s degree in Chemistry or relevant field required.
• 3+ years of experience in a clinical or industrial/pharmaceutical laboratory
• Attention to detail and ability to work in a GMP environment

Responsibilities

• 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

Skills

Attention to detail

Strong communication skills

GMP knowledge

Education

Bachelor’s degree in Chemistry

Associate’s degree in Chemistry

High School Diploma or GED with 5 years lab experience

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 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

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 & 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 & 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.