2nd shift - Operational Quality Sr. Specialist

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: Sunday-Wednesday 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.

$65-$70/hr