QA Specialist — Cleanroom GMP, 12‑Hour Day Shift (1‑Year)

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

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.