Specialist, Quality Control

Randstad USA; Marlborough (MA); On-site; USD 55,000 - 58,000; Full time

Job summary

Randstad USA in Marlborough, MA is seeking a Quality Control Specialist for a contract role (Mon–Fri). The position combines hands-on QC testing with digital workflow optimization in a state-of-the-art cGMP facility.

You will mentor QC Chemistry staff, perform HPLC analyses, contribute to SOP development, and coordinate testing across labs while partnering with digital teams to enhance LabVantage workflows.

Qualifications

• BA/BS in a scientific discipline with 2-5 years of QC experience in a cGMP environment.
• Hands-on proficiency with HPLC testing, data analysis, and cGMP documentation.

Responsibilities

• Provide technical mentorship and day-to-day guidance to QC Chemistry associates handling cGMP sample activities.
• Perform hands-on testing, including HPLC and chromatogram analysis.
• Author and revise SOPs, CAPAs, deviations, and change controls.
• Coordinate sample schedules and testing workflows across internal and external laboratories.
• Partner with digital teams to optimize LabVantage LIMS workflows and CTUs.
• Support audit readiness, laboratory data reviews, and COA generation.

Skills

HPLC testing and data analysis

QC documentation

on-call coverage

Education

Bachelor's degree in a scientific discipline

MS in a scientific discipline

Tools

LabVantage LIMS

Veeva

Job description

Job Summary
Advance breakthrough mRNA medicine at an automated, state-of-the-art cGMP facility in Marlborough, Massachusetts. A leading global biotechnology innovator is seeking a Quality Control Specialist to serve as an individual contributor and technical mentor for QC Chemistry operations. This Monday-Friday role pairs hands-on laboratory execution with digital workflow optimization.

Job Summary
Advance breakthrough mRNA medicine at an automated, state-of-the-art cGMP facility in Marlborough, Massachusetts. A leading global biotechnology innovator is seeking a Quality Control Specialist to serve as an individual contributor and technical mentor for QC Chemistry operations. This Monday-Friday role pairs hands-on laboratory execution with digital workflow optimization.
location: Marlbrough, Massachusetts
job type: Contract
salary: $40- 41.94 per hour
work hours: 9:00 AM - 5:00 PM
education: Bachelors Degree
Responsibilities

• Provide technical mentorship and day-to-day guidance to QC Chemistry associates handling cGMP sample activities.
• Perform hands-on testing, including high-performance liquid chromatography (HPLC) and chromatogram analysis.
• Author and revise standard operating procedures (SOPs), CAPAs, deviations, and change controls.
• Coordinate sample schedules and testing workflows across internal and external laboratories.
• Partner with digital teams to optimize LabVantage LIMS workflows and maintain CTUs.
• Support audit readiness, laboratory data reviews, and Certificate of Analysis (COA) generation.
  

Qualifications

• BA/BS in a scientific discipline with 2-5 years of QC experience (or MS with 0-3 years) in a cGMP environment.
• Hands-on proficiency with HPLC testing, data analysis, and general cGMP documentation.
• Working knowledge of current FDA, EU, and ICH guidelines, aseptic techniques, and lab safety.
• Demonstrated experience with LIMS platforms (LabVantage preferred) and electronic quality systems (Veeva).
• Flexibility to support periodic on-call, weekend, or holiday operational coverage as needed.
  

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. If you require a reasonable accommodation to make your application or interview experience a great one, please contact [e-mail].
Pay offered to a successful candidate will be based on several factors including the candidate’s education, work experience, work location, specific job duties, certifications, etc. In addition, Randstad offers a comprehensive benefits package, including: medical, prescription, dental, vision, AD&D, and life insurance offerings, short-term disability, and a 401K plan (all benefits are based on eligibility).
This posting is open for thirty (30) days.
It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability.