QC Associate: Bioassays & Molecular Biology (cGMP) On-Site

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

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.