QC Associate – Bioassays & Molecular Biology (cGMP)

JMD Technologies Inc.; Norwood (MA); On-site; USD 41,000 - 55,000; Full time

Job summary

JMD Technologies Inc. in Greater Norwood Area, MA seeks a QC Associate - Bioassays & Molecular Biology (cGMP) on a 6+ month contract. You will support cGMP QC testing of materials and finished products, execute critical analytical methods, and help ensure regulatory compliance.

The role involves mammalian cell-based potency assays, qPCR, sequencing, ELISA, protein analysis, aseptic technique, and SOP/document maintenance, with participation in audits and CAPAs as needed.

Qualifications

• Hands-on experience in a cGMP laboratory setting.
• Experience with mammalian cell culture and cell-based assays.
• Proficiency in aseptic technique and BSC operation.
• Familiarity with FDA/ICH regulations and quality guidelines.

Responsibilities

• Execute QC methods including mammalian cell-based potency assays, qPCR, sequencing, and protein analysis.
• Perform aseptic reagent prep, equipment maintenance, and logbook reviews.
• Assist in troubleshooting analytical equipment and assay issues within a biosafety environment.
• Write, revise, and maintain SOPs, protocols, reports, and related cGMP documentation.
• Assist in the execution of quality records, including deviations/investigations, change controls, and CAPAs.
• Support internal/external audits and collaborate on continuous quality improvement initiatives.

Skills

cGMP lab experience

Mammalian cell culture

Cell-based potency assays

ELISA

Molecular biology

Aseptic technique

Tools

Biological Safety Cabinet (BSC)

Job description

Title: QC Associate - Bioassays & Molecular Biology (cGMP)

Location: Greater Norwood Area, MA (On-Site)

Employment Type: 6+ Months Contract (possible extension or conversion)

Status: Accepting Candidates

No. of position: 2 [Level I: (0-2 Years' Experience) Level II: (3-5 Years' Experience)]

About the role

Support cGMP QC testing for raw materials, drug substances, and finished products across manufacturing facilities and affiliated contract organizations. Execute and troubleshoot critical analytical methods while driving compliance with regulatory and quality standards.

Key Responsibilities

• Execute QC methods including mammalian cell-based potency assays, qPCR, sequencing, and protein analysis.
• Perform general laboratory operations, including aseptic reagent preparation, equipment maintenance, and logbook reviews.
• Assist in troubleshooting analytical equipment and assay-related issues within a biosafety environment.
• Write, revise, and maintain SOPs, protocols, reports, and related cGMP documentation.
• Assist in the execution of quality records, including deviations/investigations, change controls, and CAPAs.
• Support internal/external audits and collaborate on continuous quality improvement initiatives.

Qualifications

• Hands-on experience in a cGMP laboratory setting executing mammalian cell culture, cell-based potency assays, ELISA, and molecular biology.
• Proficiency in aseptic techniques, micro-pipetting, and operating within a Biological Safety Cabinet (BSC).
• Experience with laboratory instrumentation calibration, maintenance, and reagent preparation.
• Familiarity with FDA, EU, and ICH regulations and quality guidelines.

Compensation (MA Pay Transparency)

• Estimated hourly range: $30.00-$40.00/hr (W-2).
• Final rate within this range will be based on skills, experience, and interview results