GMP Quality Assurance Specialist Job Boston area,Massachusetts USA,Quality Assurance

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).