Senior QC Chemistry Specialist - Onsite, cGMP & Automation

Randstad USA; Marlborough (MA); On-site; USD 62,000 - 63,000; Full time

Benefits offered by this job

Medical, prescription, dental, vision,

Short-term disability

401K plan

Job summary

Randstad USA is seeking a Quality Control Specialist – QC Chemistry (Individualized Neoantigen Therapy) in Marlborough, MA. The role is 100% onsite with Day 1 onboarding in Norwood, MA, and a Monday–Friday schedule (First shift, 8 AM–5 PM).

You will mentor associates, oversee cGMP testing and sample management, and work with Digital teams to improve LabVantage LIMS workflows. The ideal candidate has a BS in a scientific discipline with 2–5 years of QC experience in a cGMP environment (MS with

Qualifications

• BS in a scientific discipline with 2–5 years of QC experience in a cGMP environment (or MS with 0–3 years).
• Hands-on experience with LIMS (LabVantage preferred) and document management systems (e.g., Veeva).
• Solid foundation in FDA, EU, and ICH guidelines.
• Proficiency in aseptic technique, gowning protocols, and laboratory safety practices.

Responsibilities

• Provide daily technical leadership to QC Chemistry and Development labs to ensure timely, compliant cGMP sample processing and quality records.
• Apply hands-on HPLC expertise and chromatogram analysis to support QC Chemistry workflows.
• Author and revise SOPs, protocols, deviations, CAPAs, and change controls; support data reviews and COA generation.
• Partner with Digital teams to optimize LabVantage LIMS for sample coordination and data integrity.
• Lead troubleshooting for compliance and sample management issues; maintain CTUs and safe lab environment.

Skills

Microbiology

Quality Control

cGMP

GMP

Chemistry

Education

Bachelor's degree

Tools

LabVantage LIMS

Veeva

Job description

Randstad USA is seeking a Quality Control Specialist – QC Chemistry (Individualized Neoantigen Therapy) in Marlborough, MA. The role is 100% onsite with Day 1 onboarding in Norwood, MA, and a Monday–Friday schedule (First shift, 8 AM–5 PM).

You will mentor associates, oversee cGMP testing and sample management, and work with Digital teams to improve LabVantage LIMS workflows. The ideal candidate has a BS in a scientific discipline with 2–5 years of QC experience in a cGMP environment (MS with