Quality Assurance - Compliance Specialist III, Validation

Follow Your Genki to FUJIFILM Diosynth Biotechnologies (FDB)

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.

Summary: 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.

Essential Functions:

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.

Required Skills & Abilities:

• 5-10 years 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 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.

Working Conditions & Physical Requirements:

The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. While performing the duties of this job, the employee is regularly required to:

• Experience prolonged standing, some bending, stooping, and stretching.
• Ability to sit for long periods to work on a computer.
• Potential for exposure to chemicals, gases, fumes, odors, dusts, and other hazardous materials.
• Ability to wear personal protective equipment including but not limited to safety glasses, lab coat, gloves, specialized clothing including laboratory scrubs (pants and shirt), cleanroom (ISO 8 to ISO 5) gowning material and appropriate shoes required in most areas associated with this position.
• Lifting up to 25 pounds on occasion.
• Use hand-eye coordination and manual dexterity sufficient to operate a keyboard, photocopier, telephone, calculator, and other office equipment is required.
• Must be willing to work flexible hours, weekends as needed.
• Must be willing to travel occasionally, as needed.
• Attendance is mandatory.

Qualifications:

• High school or equivalent: 8 years or more experience in Pharmaceutical or other regulated Industry.
• Associates Degree: 5 years or more experience in Pharmaceutical or other regulated Industry.
• Bachelor's degree: 3 years or more experience in Pharmaceutical or other regulated Industry.
• Master's Degree: 1 year or more experience in Pharmaceutical or other regulated Industry.

Preferred Qualifications:

• Degree in Biology, Chemistry or Engineering

We are an equal opportunity and affirmative action employer. All qualified applicants will receive consideration without regard to race, color, national origin, sex, gender identity, sexual orientation, religion, disability, protected veteran status or any other characteristic protected by applicable federal, state, or local law.

If an accommodation to the application process is needed, please email FDBTHR@fujifilm.com or call 979-431-3528.