GMP Operational Quality Assurance Senior Specialist (Contract) 845

Vertex Pharmaceuticals LLC; Boston (MA); On-site; USD 83,000 - 90,000; Full time

Job summary

Vertex Pharmaceuticals LLC seeks a Senior Quality Specialist (1st Shift) in Boston to serve as an expert in quality assurance and compliance. Responsibilities include coordinating GMP activities across clinical and commercial Drug Product manufacturing and disposition, reviewing data, approving CoAs, and guiding product release.

The role is on-site, four days per week, with overtime eligibility and a temporary agency assignment.

Qualifications

• Demonstrated success by independently leading cross-functional teams.
• Experience providing QA support and oversight of GMP manufacturing operation including equipment/ facilities qualification, utilities and batch release.
• Experience leading event investigations, Root Cause Analysis and CAPA; familiarity with Oracle or Veeva systems.
• Master’s degree with 2-3 years of relevant work experience, or bachelor’s degree with 5+ years of relevant background.

Responsibilities

• Review batch data, including batch records, deviations, in-process data, EM data, QC release testing and other quality systems.
• Approve CoAs, generate BSE/TSE statements and product labelling.
• Archive batch records and documents in eDMS.
• Provide QA support for product release and disposition decisions; support quality investigations and issues.

Skills

Quality assurance

GMP

CAPA

Root Cause Analysis

Team leadership

Education

Master's degree in science/health

Bachelor's degree in science

Tools

Oracle

Veeva

Job description

Job Description

The Senior Quality Specialist (1st Shift) is recognized as an expert in the principles and application of quality assurance and compliance. The Senior Quality Specialist coordinates GMP activities in support of clinical and commercial Drug Product manufacturing and disposition.

SHIFT: Sunday-Wednesday 7:00am - 5:30pm

KEY DUTIES AND RESPONSIBILITIES:

• Review batch data, including batch records, deviations, in-process data, EM data, QC release testing and other quality systems.
• Responsible for approval of CoAs, generating BSE/TSE statement and product labelling.
• Responsible for archival of batch records and other supporting documents in electronic Document Management System (eDMS).
• Provide production floor support and provide guidance for GMP product quality and compliance for product release, including resolution of product quality investigations and quality issues of a significant nature, and provides direction for product disposition decisions including shipment.
• Review and approval of Manufacturing documents.
• Responsible for raw material release, area / line clearance and equipment release.
• May be required to assist with activities associated with equipment, utilities, and/or facility qualification activities including change control, and support of site programs.
• Provide QA support for change controls, GMP investigations and CAPAs.
• Participate in QA walkthroughs and help drive the closure of audit observations.
• Responsible for identifying risks and communicating gaps for GMP process/systems.
• Responsible for identifying risks and communicating any gaps for quality processes optimization for area/equipment release, material disposition, quality systems etc.
• Participate in continuous improvements of department processes.
• Participate in inspection readiness and support activities.
• Participate in process improvement initiatives and ongoing Project (as necessary).
• Act as a trusted advisor to the site by providing compliance guidance through collaborative review and working with the business owners to gain a better understanding of their needs and facilitate resolution of quality issue in a timely manner.

REQUIRED EDUCATION AND EXPERIENCE:

• Demonstrated success by independently leading cross-functional teams
• Experience providing QA support and oversight of GMP manufacturing operation including equipment/ facilities qualification, utilities and batch release.
• Experience successfully leading event investigations, Root Cause Analysis and CAPA Experience with network-based applications such as Oracle, Veeva
• Master’s degree with 2-3 years of relevant work experience, or bachelor's degree in a scientific or allied health field with minimum 5 years of relevant work experience, or relevant comparable background.

On-Site Roles

In this 1st shift, on-site designated role, you will work four days per week on-site (Boston)

Pay Range

$60-$65/hr

temporary role with a third-party agency partner on assignment at Vertex Pharmaceuticals (“Vertex”).

In addition, this role will be eligible for overtime pay, in accordance with federal and state requirements.