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QA Specialist III, Compliance

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Job LocationsUS-TX-College Station

Posted Date

7 days ago

(12/26/2024 12:31 PM)

Requisition ID : 2024-32484

Category : Quality Assurance

Company (Portal Searching) : FUJIFILM Diosynth Biotechnologies

Overview

The work we do at FDB has never been more importantand we are looking for talented candidates to join us. We are growing our locations, our capabilities, and our teams, and looking for passionate, mission-driven people like you who want to make a real difference in peoples lives. Join FDB and help create the next vaccine, cure, or gene therapy in partnership with some of the most innovative biopharma companies across the globe. We are proud to cultivate a culture that will fuel your passion, energy and drive - what FDB call Genki.

External US

College Station, Texas may be a small, university town, but the lively cultural scene and local amenities make it a great place for families as well as those who want the ease of small-town life and the convenience of living close to the vibrant pulse of big cities. Eighty-seven percent of Texas' population lives within a 180-mile radius, so we are in the center of it all in Texas. And our site is nestled in the hub of innovation, representing a source of pride for the area.

The QA Specialist III, QA Compliance, will be responsible for the review and approval of commissioning/qualification/Compliance protocols, reports, computer automation Compliance protocols and final reports and discrepancies for Quality Assurance. The QA Compliance Specialist III, QA Compliance, will handle all associated responsibilities in compliance with Fujifilm quality policies and site SOPs to ensure regulatory compliance.

Reports to

Manager, QA Compliance

Work Location

College Station, TX

Primary Responsibilities:

Leadership

• Provides QA support to the Compliance team during document review to ensure the organization is complying with local and global quality standards, regulatory requirements, and partner commitments.
• Work collaboratively with other site functions to instill a Quality Culture by coaching in the application of GMP Principles including the underlying rational of those principles.
• Knowledge and understanding of Computer cGMP regulations and practices pertaining to computer Compliance principles, manufacturing processes, quality systems, engineering design fundamentals, SOPs, regulatory agency expectations and industry trends.
• Reviews computer test automation scripts, creation, and deviation closure recommendations as required.
• Set up and maintain QA Compliance Monthly Tracker.

New Business Growth

• Support client due diligence and Quality audits as well as regulatory inspections.

Compliance

Reviews and approves master plans, pre/post approval of qualification and Compliance protocols, summary reports, and associated data for conformance to regulations, SOPs, specifications, and other applicable acceptance criteria.

Reviews and approves qualification and Compliance deviations and discrepancies, supports investigations and corrective actions.

Participate in design reviews and have experience in reading PandIDs and various engineering drawings.

Coordinate with Compliance, Metrology, Facilities, Engineering, on a daily basis to ensure any GMP prot