GMP QC Analytics Specialist - Batch Release & Investigations

Redbock - an NES Fircroft company; San Diego (CA); On-site; USD 85,000 - 120,000; Full time

Job summary

Redbock, on behalf of a biopharmaceutical client, seeks a QC Specialist to support GMP analytical review across clinical and commercial programs. You will review GMP data, support batch release, stability, and in‑process testing, and manage investigations.

The ideal candidate has a strong analytical chemistry background and experience with CoA review, external labs, and hands-on with Waters Empower or Agilent OpenLab. This 12-month contract offers exposure across the product lifecycle.

Qualifications

• Bachelor's degree in Chemistry, Biochemistry, Pharmaceutical Sciences, or related field.
• 4–8 years of pharmaceutical/biotech experience in QC/Analytical Chemistry or GMP environment.
• Experience reviewing GMP analytical data and supporting documentation.
• Experience reviewing analytical data packages from external labs, CMOs, CROs, or contract testing organizations.
• Hands-on experience with Waters Empower and/or Agilent OpenLab.
• Strong understanding of GMP regulations, data integrity, and documentation practices.

Responsibilities

• Review and approve GMP analytical data supporting drug product release, stability studies, raw materials, and in‑process testing.
• Perform analytical review of CoAs, batch release documentation, and supporting records.
• Review vendor-generated analytical data packages for accuracy and compliance.
• Evaluate chromatography results, trends, and raw data to ensure data integrity.
• Collaborate with external testing labs and CMOs to resolve analytical questions.

Skills

Analytical chemistry

GMP compliance

CoA review

Data integrity

Chromatography

Vendor collaboration

Analytical data review

OpenLab Empower

Education

Bachelor's degree in Chemistry/Biochemistry/Pharmaceutical Sciences

Tools

Waters Empower

Agilent OpenLab

Job description

Redbock, on behalf of a biopharmaceutical client, seeks a QC Specialist to support GMP analytical review across clinical and commercial programs. You will review GMP data, support batch release, stability, and in‑process testing, and manage investigations.

The ideal candidate has a strong analytical chemistry background and experience with CoA review, external labs, and hands-on with Waters Empower or Agilent OpenLab. This 12-month contract offers exposure across the product lifecycle.