Senior Quality Control Analyst — GMP & Process Improvement

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

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.