2nd shift - Operational Quality Sr. Specialist (Contract) 829

Vertex Pharmaceuticals LLC; Boston (MA); On-site; USD 90,000 - 96,000; Full time

Job summary

Vertex Pharmaceuticals LLC in Boston, MA is seeking a Senior Quality Specialist (2nd Shift) to lead QA activities ensuring GMP compliance for clinical and commercial Drug Product manufacturing and disposition. The role covers review of batch data, approvals of CoAs, labeling, change controls, CAPAs, and support for inspections, with a focus on timely resolution of quality issues.

Candidates should have a Master’s degree with 2-3 years (or Bachelor’s with 5+ years) in a scientific field and

Qualifications

• Experience leading cross-functional QA teams.
• QA support and oversight of GMP manufacturing including equipment/facilities qualification.
• Experience leading investigations and CAPA.
• Experience with Oracle/Veeva and network-based applications.

Responsibilities

• Review batch data, including batch records, deviations, in-process data, EM data, QC release testing and other quality systems.
• Approval of CoAs, generating BSE/TSE statement and product labelling.
• Archival of batch records and other supporting documents in eDMS.
• Provide QA support for product release and disposition decisions including handling quality investigations and issues.
• Review and approval of Manufacturing documents.
• Support change controls, GMP investigations and CAPAs.
• Participate in QA walkthroughs and drive closure of audit observations.
• Identify risks and communicate gaps for GMP processes and systems.

Skills

QA oversight

GMP manufacturing

Root Cause Analysis

CAPA

Change control

Documentation review

Oracle

Veeva

Education

Master's degree + 2-3 years

Bachelor's degree in science + 5+ years

Tools

Oracle

Veeva

eDMS

Job description

Job Description

The Senior Quality Specialist (2nd 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: Wednesday-Saturday 12:30pm est - 11:00pm est

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.

Pay Range

$65-$70/hr