Quality Control Associate II: Molecular Biology & GMP

Randstad USA; Norwood (MA); On-site; USD 41,000 - 45,000; Full time

Job summary

Randstad USA seeks a Quality Control (QC) Technician for an on-site role in Norwood, MA. The position supports cGMP QC testing for raw materials, drug substances, and finished products, executing and troubleshooting analytical methods and maintaining SOPs and documentation.

The ideal candidate has a BA/BS and 3–5 years' experience in a cGMP lab, with mammalian cell culture, cell-based and potency assays, ELISA, and molecular biology expertise.

Qualifications

• BA/BS Degree required.
• 3-5 years in a cGMP laboratory setting with hands-on experience in mammalian cell culture and related assays.
• Experience with ELISA and protein analysis is preferred.

Responsibilities

• Execute QC molecular biology and bioassay methods including potency, qPCR, sequencing and protein analysis.
• Troubleshoot equipment and assay issues and support method transfers and qualifications.
• Perform general lab support: reagent prep, equipment maintenance, housekeeping, logbooks.
• Establish and maintain a safe laboratory working environment.
• Write, revise and maintain SOPs, protocols and reports.
• Support training and assist in quality records (investigations, CAPAs).
• Ensure compliance with cGMP documentation and regulatory guidelines.
• Be accountable for mandatory training and tasks and provide audit support.

Skills

Mammalian cell culture

Cell-based assays

Potency assays

ELISA

Molecular biology

Protein analysis

Education

BA/BS Degree

Tools

pH meters

Balances

Pipettes

Job description

Randstad USA seeks a Quality Control (QC) Technician for an on-site role in Norwood, MA. The position supports cGMP QC testing for raw materials, drug substances, and finished products, executing and troubleshooting analytical methods and maintaining SOPs and documentation.

The ideal candidate has a BA/BS and 3–5 years' experience in a cGMP lab, with mammalian cell culture, cell-based and potency assays, ELISA, and molecular biology expertise.