On-the-Floor GMP QA Specialist — 2nd Shift

Atrium; Boston (MA); On-site; USD 98,000 - 106,000; Full time

Benefits offered by this job

Atrium Care Package

Job summary

Atrium in Boston seeks a GMP Quality Assurance Specialist to join a growing operational quality team on the second shift (12:30 PM - 11:00 PM). You will serve as the on-the-floor quality expert, providing real-time GMP oversight, batch record review, deviation triage, and compliance guidance to manufacturing operations.

This 12-month contract role involves reviewing manufacturing documents, CoA approvals, and supporting product release, investigations, and CAPA activities, with 40 hours per week

Qualifications

• Bachelor's or Master's degree with relevant experience in cGMP manufacturing.
• 5+ years of QA experience in a cGMP environment; 2-3 years with a Master's degree.
• Experience leading cross-functional teams and supporting GMP operations.

Responsibilities

• Review batch data and quality system records (batch records, deviations, in-process data, EM data, QC release testing).
• Approve CoAs, support product labeling, and generate BSE/TSE statements.
• Archive batch records in an electronic Document Management System (eDMS).
• Provide floor-based QA support for product release, investigations, and CAPA closure.

Skills

GMP experience

Quality Assurance

Cross-functional leadership

CAPA experience

GxP

Education

Bachelor's degree

Master's degree

Tools

Oracle

Veeva

Job description

Atrium in Boston seeks a GMP Quality Assurance Specialist to join a growing operational quality team on the second shift (12:30 PM - 11:00 PM). You will serve as the on-the-floor quality expert, providing real-time GMP oversight, batch record review, deviation triage, and compliance guidance to manufacturing operations.

This 12-month contract role involves reviewing manufacturing documents, CoA approvals, and supporting product release, investigations, and CAPA activities, with 40 hours per week