QC Analyst - Potency

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

Job Title: QC Analyst - Potency
Location: Rockville, MD
Type: Contract
Schedule: Monday - Friday 8am-5pm

Overview

Biopharmaceutical Company is seeking a QC Analyst to join their team in Rockville, MD!

Responsibilities

• Perform testing and analysis of potency samples in accordance with established protocols and Good Manufacturing Practices (GMP).
• Ensure accurate documentation of test results and maintain thorough records for compliance and audit purposes.
• Operate laboratory instrumentation such as 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, adhering to safety standards and company policies.
• Collaborate with quality assurance and manufacturing teams to support product release and stability studies.

Job Title: QC Analyst - Potency
Location: Rockville, MD
Type: Contract
Schedule: Monday - Friday 8am-5pm

Overview

Biopharmaceutical Company is seeking a QC Analyst to join their team in Rockville, MD!

Responsibilities

• Perform testing and analysis of potency samples in accordance with established protocols and Good Manufacturing Practices (GMP).
• Ensure accurate documentation of test results and maintain thorough records for compliance and audit purposes.
• Operate laboratory instrumentation such as 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, adhering to safety standards and company policies.
• Collaborate with quality assurance and manufacturing teams to support product release and stability studies.

Requirements

• Bachelor’s degree in Chemistry, Biology, Biochemistry, or a related scientific field.
• 4-5 years of experience in GMP environment performing ELISA's, MSD, and bioassays for potency residuals within a biotech company.
• Experience with good documentation practices required. (may consider CLIA or GLP experience if candidates do not have GMP)

System One, and its subsidiaries including Joulé and Mountain Ltd., are leaders in delivering outsourced services and workforce solutions across North America. We help clients get work done more efficiently and economically, without compromising quality. System One not only serves as a valued partner for our clients, but we offer eligible employees health and welfare benefits coverage options including medical, dental, vision, spending accounts, life insurance, voluntary plans, as well as participation in a 401(k) plan.

System One is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex (including pregnancy, childbirth, or related medical conditions), sexual orientation, gender identity, age, national origin, disability, family care or medical leave status, genetic information, veteran status, marital status, or any other characteristic protected by applicable federal, state, or local law.

#M-3

Ref: #558-Scientific