GMP QA Specialist | On-the-Floor Oversight, 2nd Shift

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

Benefits offered by this job

Atrium Care Package available

Job summary

A GMP Quality Assurance Specialist is being sought for a 12-month contract in Boston to support clinical and commercial drug product manufacturing on the second shift (12:30 PM - 11:00 PM). The role involves real-time GMP oversight, batch record review, deviation triage, and guidance to manufacturing operations.

The ideal candidate has 5+ years of GMP QA experience in a cGMP environment, with 2-3 years for a Master’s degree, and experience leading cross-functional teams.

Qualifications

• 5+ years of GMP QA experience in a cGMP manufacturing environment.
• Experience leading cross-functional teams and QA support for manufacturing operations.
• Experience with batch release, deviations, CAPA, and investigations.
• Experience with QA oversight of GMP facilities, equipment, and utilities.

Responsibilities

• Review batch data, batch records, deviations, and in-process data.
• Approve CoAs, generate BSE/TSE statements, support labeling.
• Archive batch records and documents in eDMS.
• Provide QA support for product release, investigations, and disposition decisions.
• Review and approve manufacturing documents and change controls.
• Support equipment, utilities, and facility qualification activities.

Skills

GMP Quality Assurance

Cross-functional leadership

QA oversight

CAPA

Education

Bachelor's degree in science or allied health

Master's degree in relevant field

Tools

Oracle

Veeva

eDMS

Job description

A GMP Quality Assurance Specialist is being sought for a 12-month contract in Boston to support clinical and commercial drug product manufacturing on the second shift (12:30 PM - 11:00 PM). The role involves real-time GMP oversight, batch record review, deviation triage, and guidance to manufacturing operations.

The ideal candidate has 5+ years of GMP QA experience in a cGMP environment, with 2-3 years for a Master’s degree, and experience leading cross-functional teams.