Pharma Quality Control (QC) Associate

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

Join Our Team: Quality Control (QC) Technician

Pay Rate: $30-33 per hour (based on experience)

About the Role

The Quality Control Associate II will support cGMP QC testing for raw materials, drug substances, and finished products at the company's manufacturing facility and affiliated contract organizations. This role includes executing and troubleshooting analytical methods, supporting method transfers, qualification activities, and ensuring compliance with cGMP standards. This is an on-site position.

Here’s What You’ll Do

• 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.

Here’s What You’ll Need (Basic Qualifications)

Education: BA/BS Degree

Experience: STEM degree with 3-5 years of experience in a cGMP laboratory setting, with hands-on experience in mammalian cell culture, cell based and potency assays, ELISA, molecular biology, and Protein Analysis.

Here’s What You’ll Bring to the Table (Preferred 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.
• Location: Full-time on-site in Norwood, MA (Not eligible for remote work).

Why This Opportunity?

This role puts you at the heart of quality control operations, providing essential stability to a high-performing bioassay team. You will sharpen your GMP expertise, master data integrity protocols, and play a direct role in maintaining the highest standards of regulatory compliance.