Quality Assurance Specialist - Manufacturing Floor

Responsibilities: Provide on-the-floor QA oversight for active GMP manufacturing and cleanroom operations. Review executed batch records, logbooks, and GMP documentation for accuracy and compliance. Support investigations, deviations, CAPAs, and change controls alongside senior QA personnel. Partner with cross-functional teams (Manufacturing, QC) to uphold approved site SOPs and regulatory standards. Assist with site inspection readiness, internal audits, and external client audits.

Qualifications: Bachelor's degree in Life Sciences, Engineering, Microbiology, or related technical discipline (or equivalent practical experience). 1+ years of GMP industry experience within a biotech or pharmaceutical manufacturing environment. Working knowledge of FDA, EMA, and ICH GMP regulations and quality systems. Proven ability to review technical batch documentation with high attention to detail. Willingness and ability to work in classified cleanroom environments wearing required PPE, including rotating 12-hour day shifts. Skills GMP, Quality Assurance, Batch Record Review, CAPA, Deviations, Change Control, Cleanroom Operations, FDA Compliance, SOP Adherence, Life Sciences, Root Cause Analysis

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. 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.