GMP Quality Assurance Specialist

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

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).