GMP Quality Assurance Specialist - 410772

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

Client Overview

Our client is a leading global biotechnology company in Boston focused on developing transformative medicines for patients with serious diseases and is seeking a GMP Quality Assurance Specialist to join a growing operational quality team.

Salary/Hourly Rate

$71.50/hr - $77/hr

Position Overview

We are seeking a GMP Quality Assurance Specialist to join a growing operational quality team supporting clinical and commercial drug product manufacturing on second shift (12:30 PM - 11:00 PM). As the GMP Quality Assurance Specialist, you will be the on-the-floor quality expert, providing real-time GMP oversight, batch record review, deviation triage, and compliance guidance to manufacturing operations. This is a 12-month contract, 40 hours per week.

Responsibilities Of The GMP Quality Assurance Specialist

• Review batch data including batch records, deviations, in-process data, EM data, QC release testing, and other quality system records.
• Approve CoAs, generate BSE/TSE statements, and support product labeling.
• Archive batch records and supporting documents in an electronic Document Management System (eDMS).
• Provide production floor support and GMP compliance guidance for product release, quality investigations, and product disposition decisions.
• Review and approve manufacturing documents.
• Perform raw material release, area/line clearance, and equipment release.
• Support equipment, utilities, and facility qualification activities, including change control.
• Provide QA support for change controls, GMP investigations, and CAPAs.
• Participate in QA walkthroughs and drive closure of audit observations.
• Identify risks and communicate gaps in GMP processes, systems, and quality processes.
• Participate in continuous improvement, process improvement initiatives, and inspection readiness.
• Act as a trusted compliance advisor to site business owners to resolve quality issues in a timely manner.

Required Experience/Skills For The GMP Quality Assurance Specialist

• 5+ years of experience as a GMP Quality Assurance Specialist or in a similar QA role in a cGMP manufacturing environment (2-3 years with a Master's degree).
• Demonstrated success independently leading cross-functional teams.
• Experience providing QA support and oversight of GMP manufacturing operations, including equipment/facilities qualification, utilities, and batch release.
• Experience leading event investigations, root cause analysis, and CAPA.
• Experience with network-based applications such as Oracle and Veeva.

Preferred Experience/Skills For The GMP Quality Assurance Specialist

• Background as a GMP Quality Assurance Specialist supporting cell and gene therapy or sterile drug product manufacturing.
• Experience with batch disposition, CoA approval, and eDMS.
• Inspection readiness experience.
• Comfort working a 2nd shift schedule.

Education Requirements

• Bachelor's degree in a scientific or allied health field with 5+ years of relevant experience, or Master's degree with 2-3 years of relevant experience.

Benefits

• Atrium Care Package available, upon eligibility (including healthcare plans, discount programs, and paid time off).