Quality Control Associate – Biologics

About the Job

Role: Quality Control Associate – Biologics

Location: Norwood, MA – On-Site

Employment Type: Contract

Duration: 6 Months

Schedule: Monday–Friday, 8:00 AM–5:00 PM

Status: Accepting Candidates

About the Role

We are seeking a Quality Control Associate – Biologics to support molecular biology and bioassay testing within a cGMP laboratory environment. The ideal candidate will have hands-on experience with mammalian cell-based assays, molecular biology techniques, and analytical testing.

Key Responsibilities

• Perform QC molecular biology and bioassay testing, including mammalian cell-based potency assays, qPCR, sequencing, ELISA, and protein analysis.
• Troubleshoot equipment and assay-related issues.
• Prepare reagents and perform equipment maintenance and logbook reviews.
• Support general laboratory activities and maintain a safe laboratory environment.
• Develop, revise, and maintain SOPs, protocols, and reports.
• Support investigations, change controls, CAPAs, audits, and training activities.
• Ensure compliance with cGMP documentation and regulatory requirements.
• Support method transfers, qualification, development, and continuous improvement initiatives.
• Collaborate effectively with cross-functional teams in a fast-paced laboratory environment.

Required Qualifications

• Bachelor's degree in a STEM-related field.
• Relevant experience in a cGMP laboratory environment.
• Hands-on experience with molecular biology and/or bioassay testing.
• Experience with mammalian cell culture, cell-based potency assays, qPCR, ELISA, sequencing, or protein analysis.
• Strong documentation, communication, and organizational skills.
• Ability to work effectively in an on-site laboratory environment.

Compensation

Estimated Hourly Range:

• Level I: $30–$35/hr — 0–2 years of experience
• Level II: $35–$40/hr — 3–5 years of experience

Final compensation will be based on skills, experience, and interview results.