Overview
QA Specialist III, QA Compliance (On-Site in College Station, TX) Jobs in United States at FUJIFILM Biotechnologies
Title: QA Specialist III, QA Compliance (On-Site in College Station, TX)
Company: FUJIFILM Biotechnologies
Location: United States
***This is an on-site position in College Station, TX.
Summary:
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 P&ID’s and various engineering drawings.
Coordinate with Compliance, 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:
Master’s Degree with 2+ years of experience in Pharmaceutical or other regulated Industry; OR
Bachelor’s degree with 3+ years of experience in Pharmaceutical or other regulated Industry; OR
Associate’s degree with 5+ years of experience in Pharmaceutical or other regulated Industry; OR
High school or equivalent with 8+ years of experience in Pharmaceutical or other regulated Industry.
Experience with qualification/computer Compliance experience.
Experience with qualification/Compliance 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 Compliance 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 supervision.
Proficient in Microsoft Excel, Word and PowerPoint.
All candidates must have a working knowledge of cGMP regulations for the production of drug, biologics or vaccine products.
Role model for company core values of trust, delighting our customers, Gemba, and Genki.
