Quality Assurance Specialist - Manufacturing Floor

Randstad; Plainville (MA); In loco; USD 39.000 - 41.000; Tempo pieno

Descrizione del lavoro

Randstad is seeking a Quality Assurance Specialist for a 1-year on-site contract in Plainville, MA. You will support commercial cleanroom operations, performing QA oversight on GMP manufacturing processes and reviewing batch records.

The role requires a Bachelor's degree and at least 1 year of GMP experience in biotech or pharmaceutical manufacturing. The position follows a 12-hour rotating day shift with on-site work.

Competenze

• Bachelor’s degree in Life Sciences, Engineering, Microbiology, or related discipline.
• 1+ years of GMP industry experience in biotech or pharmaceutical manufacturing.
• Working knowledge of FDA, EMA, and ICH GMP regulations and quality systems.
• Proven ability to review technical batch documentation with high attention to detail.

Mansioni

• 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.

Conoscenze

GMP

Quality Assurance

Batch Record Review

CAPA

Deviations

Change Control

Cleanroom Operations

FDA Compliance

SOP Adherence

Life Sciences

Root Cause Analysis

Formazione

Bachelor’s degree

Descrizione del lavoro

Job Summary

Join a global life sciences manufacturing leader in Plainville, MA, as a Quality Assurance Specialist. This on-site, 1-year contract role offers valuable hands‑on experience supporting commercial cleanroom operations on a predictable 12-hour rotating day shift.

location: Plainville, MA

job type: 1 year contract

pay: $28 - 30 per hour

Work Hours

• Day shift role - Flex 12 rotating


• Week 1 – M, T, F, Sa


• Week 2 – Su, W, Th


• 6:45am to 7:15pm (with 30 min lunch)

education: Bachelor’s Degree

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.

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.