QA Specialist III, QA Validation

Overview

The work we do at FDB has never been more important—and 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 people’s 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 Validation, will be responsible for the review and approval of commissioning/qualification/validation protocols, reports, computer automation validation protocols and final reports and discrepancies for Quality Assurance. The QA Specialist III, QA Validation, will handle all associated responsibilities in compliance with Fujifilm quality policies and site SOPs to ensure regulatory compliance.

 

Reports to                Manager, QA Validation

Work Location         College Station, TX 

 

Primary Responsibilities:

 

Leadership

• Provides QA support to the validation 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 validation 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 Validation 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 validation protocols, summary reports, and associated data for conformance to regulations, SOPs, specifications, and other applicable acceptance criteria
• Reviews and approves qualification and validation deviations and discrepancies, supports investigations and corrective actions.
• Participate in design reviews and have experience in reading P&ID’s and various engineering drawings.
• Coordinate with Validation, Metrology, Facilities, Engineering, on a daily basis to ensure any GMP protocols, requirements etc. are completed in a timely manner
• Utilize investigative techniques to determine root causes of discrepancies and proper corrective and preventative actions.
• Promptly notify Senior Management of potential quality or regulatory issues that may affect product quality or regulatory compliance.
• All other duties as assigned.

 

Qualifications:

• Bachelor’s degree with 3+ years of experience in Pharmaceutical or other regulated Industry.
• Associates Degree with 5+ years of experience in Pharmaceutical or other regulated Industry.
• High school or equivalent with 8+ years of experience in Pharmaceutical or other regulated Industry.

• Experience with qualification/computer validation experience.
• Experience with qualification/validation of process equipment, clean utilities, automation, sterile filling, aseptic processing, facilities, HVAC, and new construction final qualification requirements of TOP’s for GMP facilities.
• Single Use and Process Validation a plus.
• Excellent written and oral communication skills.
• Excellent organizational, analytical, data review and report writing skills.
• Ability to set personal performance goals and provide input to departmental objectives.
• Develop staff to maximize contributions to the team and the company.
• Ability to multitask and easily prioritize work.
• Ability to work independently with little supervisi