Quality Assurance - Compliance Specialist III- QA Validation

Summary: BioPharma Consulting JAD Group is seeking a highly skilled and experienced Quality Assurance - Compliance Specialist III to join our team. The Quality Assurance Compliance 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 Compliance Specialist III – QA Validation, will handle all associated responsibilities in compliance with Fujifilm quality policies and site SOPs to ensure regulatory compliance.
Functions:

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

Requirements

Qualifications:

• Bachelor’s degree with three (3) years or more experience in Pharmaceutical or other regulated Industry OR
• Associates Degree with five (5) years or more experience in Pharmaceutical or other regulated Industry OR
• High school or equivalent with eight (8) years or more experience in Pharmaceutical or other regulated Industry
• Preferred: Degree in Biology, Chemistry or Engineering

Required Skills & Abilities:

• 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.
• Proficient in Microsoft Excel, Word and PowerPoint.