Quality Control Analyst - 259267

Medix™; Gaithersburg (MD); On-site; USD 70,000 - 95,000; Full time

Job summary

Medix™ is seeking an Experienced Quality Control Analyst for Bioassays and ELISAs in Gaithersburg, MD. The role focuses on quantitative ELISA bioassays, cell culture, and routine QC testing to ensure biopharmaceutical quality.

The candidate will document results under cGMP standards, collaborate across teams, and mentor junior analysts. Open-ended contract with strong potential to convert to permanent staff.

Qualifications

• Bachelor's degree in Biology or related field.
• 2–5 years in ELISAs within GMP/GLP labs.
• Track record of quantitative ELISA bioassays or receptor-binding assays.
• Strong cell culture and pipetting skills.
• Experience with data recording and cGMP documentation.

Responsibilities

• Perform routine functional bioassay testing to support cGMP manufacturing.
• Run ELISA-based bioassays to assess target-binding, activity, and antibody reactivity across lots.
• Conduct cell culture and cell-based assays for product release and stability.
• Document test results per cGMP standards and SOPs.
• Collaborate with QC bioassay team and cross-functional groups.
• Mentor junior analysts and assist with method troubleshooting.

Skills

ELISA testing

Bioassays

Cell culture

Pipetting skills

Data analysis

cGMP knowledge

Team collaboration

Troubleshooting

Education

B.S. in Biology

Tools

ELISA methods

Job description

Experienced Quality Control Analyst – Bioassays & ELISAs (Gaithersburg, MD)

Join a dynamic and growing biopharma company in Gaithersburg, MD seeking an experienced QC Analyst with expertise in quantitative bioassays and ELISA routine testing to ensure biopharmaceutical products meet rigorous quality and functional performance specifications.

Position Duration: Open-ended, ongoing contract role with strong potential to convert to permanent staff.

Work Schedule: Standard business hours, Monday–Friday

Responsibilities:

• Ensure biopharmaceutical quality through routine functional bioassay testing in support of cGMP manufacturing operations.
• Execute ELISA-based bioassays to evaluate target-binding affinity, relative biological activity, and antibody reactivity across product lots.
• Conduct cell culture, cell-based assays, residuals, etc. for product release and stability.
• Document test results in strict accordance with cGMP standards and laboratory SOPs.
• Collaborate closely with cross-functional teams within the QC bioassay laboratory.
• Perform peer review of bioassay datasets and analytical calculations.
• Root-cause investigations and troubleshooting for ELISA methods, assay drift, standard curves, and laboratory instrumentation as needed.
• Mentor and train junior analysts as needed.

Qualifications:

• Education: Bachelor of Science in Biology or similar scientific discipline.
• Experience: 2 to 5 years of conducting ELISAs in a regulated Quality Control (GMP) or Bioanalytical (GLP) laboratory, with at least 2 years hands-on experience running routine ELISA methods.
• Key Expertise: Track record of conducting quantitative ELISA bioassays, dose-response curves, relative activity determinations, or receptor-binding assays.
• Strong experience cell culture and pipetting skills are required.
• Troubleshooting: Experience troubleshooting bioassay methods is preferred.