Quality Control Analyst II - SDF

Initial Therapeutics, Inc.; Durham (NC); On-site; USD 65,000 - 95,000; Full time

Benefits offered by this job

14 paid holidays

Health Insurance

Dental Insurance

Vision Insurance – day one

8% 401K contribution

Tuition Assistance

Life & Disability Insurance

Employee Referral Awards

Access to Novo Nordisk products

Job summary

Novo Nordisk in Durham, NC is seeking a Quality Control Analyst to perform and review analysis of in-process, release and stability samples in accordance with cGMP and site procedures. You will support transfer of technology and processes per project plans, reporting to the Senior Manager, QC – OFP.

Required: a chemistry-related degree with minimum three years of pharma lab experience and strong attention to detail; GMP knowledge is a plus.

Qualifications

• Bachelor's degree in Chemistry or related field required.
• Associate's degree with 3+ years in pharma lab considered.
• High School Diploma with 5+ years in clinical/industrial pharma lab considered.
• At least 3 years of clinical or industrial/pharmaceutical lab experience.
• Attention to detail required.

Responsibilities

• Perform and review analysis of in-process, release and stability samples per cGMP.
• Transfer of technology and processes per project plans and timelines.
• Report to Senior Manager, QC – OFP.
• Author deviations and participate in investigations.
• Maintain testing proficiency and lab data integrity.

Skills

Attention to detail

Strong communication

GMP knowledge

Education

Bachelor's degree in Chemistry

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 positionsAll employees enjoy generous paid time off including 14 paid holidaysHealth Insurance, Dental Insurance, Vision Insurance – effective day oneGuaranteed 8% 401K contribution plus individual company match optionFamily Focused Benefits including 14weeks paid parental & 6 weeks paid family medical leaveFree access to Novo Nordisk-marketed pharmaceutical productsTuition AssistanceLife & Disability InsuranceEmployee 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 DataEnvironmental ComplianceGMP Compliance of LaboratoryMaintain testing proficiency for methodsTimeliness of Lab Results & InvestigationsAnalysis of SamplesAuthor DeviationsCoaching other analystsData Trending & TrackingEnsure departmental documents are current & standardizedLaboratory Equipment Validation & System supportLaboratory IT System supportPerform deviation & change control activitiesSupports DeviationsSystematic Problem SolvingFollow all safety and environmental requirements in the performance of dutiesOther 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 experienceMay 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 laboratoryMay consider a High School Diploma or GED with a minimum of five (5) years of experience in a clinical or industrial/pharmaceutical laboratoryMinimum of three (3) years of experience in a clinical or industrial/pharmaceutical laboratory requiredMust demonstrate attention to detail required

Preferred Qualifications

• Ability to author scientific & technical reports preferredAble to perform routine testing per SOP & GMP standards preferredChange control, deviation, trending a plusKnowledgeable in GMP & laboratory techniques preferredServe as a subject matter expert on QC processes a plusStrong communication skills (verbal & written) preferredTroubleshooting for laboratory equipment a plusValidation & technical transfer experience a plusSkills 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.

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.