Senior Quality Control Analyst - GMP Lab Leader

BioSpace; Durham (NC); On-site; USD 90,000 - 120,000; Full time

Benefits offered by this job

Health Insurance

Dental Insurance

Vision Insurance

8% 401K

Job summary

Novo Nordisk in Durham, NC is seeking a QC Analyst to perform and review analysis of in-process, release and stability samples of API and/or filled product, ensuring adherence to cGMP and site policies while providing leadership to fellow analysts.

This role emphasizes data integrity, GMP lab compliance, method proficiency, and timely results. Requires a Bachelor’s degree and five years of pharmaceutical lab experience with strong communication and SME knowledge of QC processes.

Qualifications

• Bachelor’s degree from an accredited university is required.
• Five years of experience in a clinical or industrial/pharmaceutical laboratory is required.
• Ability to author scientific and technical reports.
• Strong communication skills (verbal and written) required.
• Advanced knowledge of GMP and laboratory techniques.

Responsibilities

• Perform and review analysis of in-process, release and stability samples per cGMP and SOPs.
• Provide leadership for other analysts and support tech transfer per project plans.
• Maintain data integrity and ensure timely lab results.
• Author deviations and drive process improvements within QC.

Skills

Technical reporting

Attention to detail

GMP knowledge

QC processes SME

Communication skills

Education

Bachelor’s Degree

Associate’s Degree + 7 years experience

Job description

Novo Nordisk in Durham, NC is seeking a QC Analyst to perform and review analysis of in-process, release and stability samples of API and/or filled product, ensuring adherence to cGMP and site policies while providing leadership to fellow analysts.

This role emphasizes data integrity, GMP lab compliance, method proficiency, and timely results. Requires a Bachelor’s degree and five years of pharmaceutical lab experience with strong communication and SME knowledge of QC processes.