Quality Assurance Specialist - Lab Systems & Compliance

Randstad USA; Waltham (MA); On-site; USD 48,000 - 54,000; Full time

Benefits offered by this job

Medical benefits

401K plan

Job summary

Randstad USA in Waltham, MA seeks a quality professional for a high-visibility compliance role within international analytical testing workflows. This 1st-shift contract role offers hands-on ownership of key QMS processes and global regulatory alignment.

You will manage documentation, support audits, and author SOPs while driving CAPAs, change controls, and non-conformances. Bachelor’s in Life Sciences, 1+ year QA/QC experience, and proficiency with LIMS/eDMS are expected.

Qualifications

• Bachelor’s degree in Life Sciences required.
• 1+ year QA/QC in a contract testing lab preferred.
• Familiar with regulated quality systems (GCP/ISO17025).

Responsibilities

• Manage QMS documentation and archival of analytical testing records.
• Support audit readiness and supplier/customer audits for regulatory compliance.
• Collaborate with US and international teams to author/review SOPs and guidelines.
• Lead deviation investigations, CAPAs, change controls, and non-conformance workflows.
• Review and release customer data packages and projects for delivery.
• Assist instrument qualification, maintenance scheduling, and calibration records.

Skills

QMS

ISO 17025

GCP

CAPA

Change Control

Non-Conformance

LIMS

eDMS

Equipment Qualification

Internal Audits

External Audits

SOP Authoring

Technical Review

Education

Bachelor’s degree in Biology, Biotechnology, Chemistry, or related Life Sciences

Tools

Microsoft Office

Job description

Job Summary

Step into a high-visibility compliance role with a premier global biotechnology leader in the life sciences hub of Waltham, MA. If you are a quality professional ready to drive operational excellence across international analytical testing workflows, this 1st-shift opportunity offers hands-on ownership of crucial Quality Management System (QMS) processes.

location: Waltham, MA

job type: contract, end date for this role is 2/2027 and will not extend unless business needs change

pay:$35.00 - $39.00 per hour

work hours: first shift, monday through friday, 9am - 5pm with flexibility for some early days and early outs

education:Bachelor degree in the Life Science field

Responsibilities

• Manage, organize, and archive critical Quality Management System documentation and analytical testing records.
• Facilitate audit readiness and support internal and external audits to ensure global regulatory compliance.
• Partner cross-functionally with US and international teams to author, review, and standardize SOPs and laboratory guidelines.
• Drive deviation investigations, CAPAs, change controls (CC), and non-conformance resolution workflows.
• Review, verify, and release completed customer data packages and projects for final delivery.
• Support laboratory instrument and equipment qualification, maintenance schedules, and calibration records.

Qualifications

• Bachelor’s degree in Biology, Biotechnology, Chemistry, or related Life Sciences field.
• 1+ year of QA/QC experience in a commercial or contract testing laboratory.
• Demonstrated familiarity with regulated quality systems (GCP, ISO 17025, or equivalent).
• Hands-on proficiency with Laboratory Information Management Systems (LIMS) and electronic Document Management Systems (eDMS).
• Strong working knowledge of Microsoft Office Suite.
• Solid communication, analytical, and cross-functional problem-solving skills.

Skills

Quality Management Systems (QMS), ISO 17025, GCP, CAPA, Change Control (CC), Non-Conformance Investigations, LIMS, Document Management Systems (eDMS), Laboratory Equipment Qualification, Internal Audits, External Audits, SOP Authoring, Technical Review

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.

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).

• medical
• prescription
• dental
• vision
• AD&D
• life insurance offerings
• short-term disability
• 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.