Potency QC Analyst - GMP Lab (Contract, Rockville)

Joulé; Rockville (MD); On-site; USD 85,000 - 110,000; Full time

Job summary

System One is seeking a QC Analyst - Potency in Rockville, MD, to perform potency testing and data interpretation within GMP environments. The role emphasizes accurate documentation, instrument operation (HPLC, spectrophotometers), and cross-functional collaboration for product release.

The ideal candidate holds a Bachelor’s degree in a related science and has 4–5 years of GMP experience with ELISAs, MSDs, and potency bioassays, with strong documentation practices.

Qualifications

• Bachelor's degree in a related scientific field.
• 4–5 years GMP environment experience performing ELISAs, MSDs, and potency bioassays.
• Experience with good documentation practices (GLP/CLIA acceptable if GMP not present).

Responsibilities

• Perform testing and analysis of potency samples per protocols and GMP.
• Document test results thoroughly for compliance and audit purposes.
• Operate HPLC, spectrophotometers and other analytical tools to assess sample quality.
• Interpret data, prepare reports, and communicate findings to cross-functional teams.
• Maintain a clean, organized, and compliant lab environment with safety and policy adherence.
• Collaborate with QA and manufacturing to support product release and stability studies.

Skills

GMP experience

Documentation

Data interpretation

Team collaboration

Education

Bachelor’s degree in Chemistry/Biology/Biochemistry or related

Tools

HPLC

Spectrophotometers

MSD

Job description

System One is seeking a QC Analyst - Potency in Rockville, MD, to perform potency testing and data interpretation within GMP environments. The role emphasizes accurate documentation, instrument operation (HPLC, spectrophotometers), and cross-functional collaboration for product release.

The ideal candidate holds a Bachelor’s degree in a related science and has 4–5 years of GMP experience with ELISAs, MSDs, and potency bioassays, with strong documentation practices.