Quality Control: Microbiology & Cell Culture Specialist

Randstad USA; Norwood (MA); On-site; USD 56,000 - 58,000; Full time

Job summary

Randstad USA is seeking a Quality Control Associate II for our on-site biotech manufacturing facility in Norwood, MA. You will execute cGMP QC testing across raw materials, drug substances, and finished products, driving method transfers and ensuring compliance with standards to support patient safety.

The role requires hands-on experience with molecular biology, cell-based and potency assays, ELISA, and protein analysis, with a BA/BS and 3–5 years in cGMP labs.

Qualifications

• Method development/qualification experience with molecular biology, cell-based assays, or protein analysis methods.
• Trained in Aseptic techniques and general laboratory instrumentation (e.g. pH meters, balances, pipettes)
• Ability to prepare reagents, pipette small volumes, work in a Biological Safety Cabinet
• Experience with laboratory equipment calibration and maintenance.
• Ability to work effectively in a fast-paced, cross-functional matrix environment.
• Familiarity with relevant FDA, EU, ICH guidelines, and regulations.

Responsibilities

• Execute QC molecular biology and Bioassay methods (e.g. Mammalian cell based potency, qPCR, sequencing, protein analysis)
• Assist in troubleshooting equipment and assay issues.
• Perform general laboratory support activities including reagent preparation, equipment maintenance, housekeeping, logbook reviews, etc.
• Establish and maintain a safe laboratory working environment.
• Write, revise, and maintain SOPs, protocols, and reports.
• Support training as assigned.
• Assist in execution of Quality records (i.e. investigations, change controls, CAPAs)
• Ensure compliance with cGMP documentation and regulatory guidelines.
• Accountable for all mandatory training and assigned tasks.
• Provide support during audits and collaborate on continuous improvement initiatives.
• Additional duties may be assigned.

Skills

Quality Control

Quality Assurance

cGMP

GMP

raw materials

Drug Substance

ELISA

mammalian cell culture

cell based and potency assays

molecular biology

Education

BA/BS Degree

Bachelors

Job description

Randstad USA is seeking a Quality Control Associate II for our on-site biotech manufacturing facility in Norwood, MA. You will execute cGMP QC testing across raw materials, drug substances, and finished products, driving method transfers and ensuring compliance with standards to support patient safety.

The role requires hands-on experience with molecular biology, cell-based and potency assays, ELISA, and protein analysis, with a BA/BS and 3–5 years in cGMP labs.