Senior QC Analyst – GMP Lab & Process Improvement

NCBiotech; Durham (NC); On-site; USD 85,000 - 120,000; Full time

Benefits offered by this job

Paid holidays

Health, dental & vision insurance

401K with company match

Parental & family leave

Job summary

Novo Nordisk's Emerging Technologies - Solid Dosage Forms facility in Durham, NC seeks a QA/QC Analyst to perform and review in-process, release and stability analyses of API and filled product per cGMP guidelines. You will lead other analysts in daily tasks and ensure data integrity across testing and investigations.

You should have a strong GMP background, 5+ years in pharmaceutical lab work, and be proficient in analytical methods.

Qualifications

• Bachelor’s degree required; seven years in lab acceptable with Associate’s degree.
• Five years of clinical or industrial/pharmaceutical laboratory experience.
• A publisher of scientific and technical reports; SOP & GMP testing proficiency.
• Strong attention to detail; SME for QC processes; strong written/verbal communication.

Responsibilities

• Ensure accuracy and scientific soundness of lab data.
• Maintain GMP laboratory compliance and environmental safety.
• Perform sample analysis and timely reporting of results.
• Coach other analysts and drive data trending and investigations.
• Lead deviations, change controls, and problem solving.
• Validate equipment and support laboratory IT systems.

Skills

Chemistry Analysis (HPLC, UPLC, GC, TO

Microbiology Analysis

Raw Materials Analysis

Documentation & Reporting

GMP Compliance

Data Trending & Investigation

Analytical Method Validation

Technical Report Writing

Team Coaching & Mentoring

Education

Bachelor’s Degree

Associate’s Degree with 7+ years in lab

Tools

Laboratory Equipment Validation

Job description

Novo Nordisk's Emerging Technologies - Solid Dosage Forms facility in Durham, NC seeks a QA/QC Analyst to perform and review in-process, release and stability analyses of API and filled product per cGMP guidelines. You will lead other analysts in daily tasks and ensure data integrity across testing and investigations.

You should have a strong GMP background, 5+ years in pharmaceutical lab work, and be proficient in analytical methods.