Quality Control Specialist - QC Chemistry

Quality Control Specialist – QC Chemistry (Individualized Neoantigen Therapy)

Location:

Marlborough, MA (Day 1 in Norwood, MA; 100% Onsite)

Schedule:

Monday – Friday

About the Role

We are expanding our Quality Control team to support next-generation mRNA medicine!

Our Marlborough campus is a state-of-the-art cGMP facility dedicated to clinical-to-commercial manufacturing for Individualized Neoantigen Therapy (INT). Designed with end-to-end automation, robotics, and digital infrastructure, the site spans buffer prep through drug substance and product manufacturing.

We are seeking a QC Specialist (QC Chemistry) to serve as an individual contributor, subject matter expert (SME), and technical mentor for a growing team supporting QC Chemistry and Development laboratories.

Key Responsibilities

• Technical Mentorship:
  Provide hands-on guidance and technical oversight to associates across QC Chemistry workflows.
• Testing & Sample Coordination:
  Perform and coordinate cGMP analytical testing, sample management, and routine lab readiness.
• Digital & Automation Integration:
  Partner with Digital teams to optimize Lab Vantage LIMS workflows and leverage emerging tech to drive lab efficiency.
• Compliance & Troubleshooting:
  Lead investigations, address OOS/OOT results, and ensure adherence to cGMP and SOP standards.
• Cross-functional Collaboration:
  
  Partner with Manufacturing, QA, and Development to support seamless product release.

Qualifications

• Education & Experience:
  
  BS in a scientific discipline with 2–5 years of QC experience in a cGMP environment (or MS with 0–3 years).
• Systems Knowledge:
  Hands-on experience with LIMS (Lab Vantage preferred) and document management systems (e.g., Veeva).
• Regulations:
  Solid foundation in FDA, EU, and ICH guidelines.
• Lab
  
  Skills:
  
  Proficiency in aseptic technique, gowning protocols, and laboratory safety practices.
• Adaptability:
  Comfort managing multiple priorities in a fast-paced setting; flexibility for periodic on-call or weekend coverage.

Location Details

• Primary Site: 100% onsite in Marlborough, MA.
• Onboarding:
  Day 1 orientation takes place at our Norwood, MA site.

Salary

salary: $45 - $45.14 per hour

Shift & Work Hours

shift:
First

work hours: 8 AM - 5 PM

Education

education:
Bachelors

Responsibilities

• Technical Leadership & Operations: Provide daily guidance to associates across QC Chemistry and Development labs, coordinating schedules to ensure safe, timely cGMP sample processing, testing, and quality records across internal and external sites.
• HPLC & Hands-on Testing: Apply hands‑on HPLC expertise and chromatogram analysis to directly support QC Chemistry operations and analytical workflows.
• Documentation & Compliance: Author and revise SOPs, protocols, deviations, CAPAs, and change controls; support data reviews, COA generation, and internal/external audit teams.
• Systems & Digital Optimization: Partner with the Digital team to optimize Lab Vantage LIMS for sample coordination, and explore compliant generative AI tools to enhance workflows within data-integrity controls.
• Lab Environment & Troubleshooting: Lead troubleshooting for compliance and sample management issues, while maintaining CTUs and establishing a safe, compliant laboratory environment.

Skills

• Microbiology (5 years of experience is required)
• Quality Control (5 years of experience is required)
• cGMP (5 years of experience is required)
• GMP (5 years of experience is required)
• chemistry (3 years of experience is required)

Qualifications (duplicate?)

• Years of experience: 2 years
• Experience level:
  Experienced

Equal Opportunity Employer

Equal Opportunity

Employer:

Race, Color, Religion, Sex, Sexual Orientation, Gender Identity, National Origin, Age, Genetic Information, Disability, Protected Veteran Status, or any other legally protected group status.

At Randstad, we welcome people of all abilities and want to ensure that our hiring and interview process meets the needs of all applicants.

Benefits

• medical, prescription, dental, vision, AD&D, and life insurance offerings
• short-term disability
• 401K plan (all benefits are based on eligibility)

Experience

• Experienced
• 2 years

Education

• Bachelors