Senior Quality Control Analyst – GMP & Process Improvement

BioSpace; Durham (NC); On-site; USD 90,000 - 110,000; Full time

Benefits offered by this job

Annual bonus

14 paid holidays

Health, dental, vision insurance

8% 401K contribution with companyMatch

Parental & family leave

Tuition assistance

Life & disability insurance

Employee referral awards

Job summary

Novo Nordisk in Durham, NC is seeking a QC Analyst to perform and review analyses of in-process, release, and stability samples per cGMP. You will provide leadership to other analysts, transfer of technology, and ensure timely results while upholding environmental and GMP standards.

The role requires a strong background in chemistry, microbiology or raw materials analysis, plus five years in a pharma lab. Excellent communication is essential.

Qualifications

• Bachelor’s Degree from an accredited university required.
• May consider an Associate’s Degree with seven years of relevant laboratory experience.
• Five years of experience in a clinical or industrial/pharmaceutical laboratory.
• Ability to author scientific and technical reports.
• Able to perform routine testing per SOP and GMP standards.
• Advanced knowledge of GMP and laboratory techniques.
• Demonstrate attention to detail.
• Serve as a subject matter expert on QC processes.

Responsibilities

• Ensure accuracy and scientific soundness of lab data.
• Maintain environmental compliance and GMP laboratory standards.
• Support deviations and change controls.
• Maintain testing proficiency for methods.
• Ensure timely laboratory results and investigations.
• Perform analysis of samples.
• Coach other analysts.
• Develop process competence across IFP/API.
• Drive process improvement for Site QC.
• Ensure all analyst testing is completed as needed.

Skills

Chemistry Analysis

Microbiology Analysis

Raw Materials Analysis

Communication Skills

Education

Bachelor’s Degree

Tools

GMP Laboratory Equipment

Job description

Novo Nordisk in Durham, NC is seeking a QC Analyst to perform and review analyses of in-process, release, and stability samples per cGMP. You will provide leadership to other analysts, transfer of technology, and ensure timely results while upholding environmental and GMP standards.

The role requires a strong background in chemistry, microbiology or raw materials analysis, plus five years in a pharma lab. Excellent communication is essential.