QA Specialist III Compliance

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

The work we do at FUJIFILM Diosynth Biotechnologies 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 missiondriven 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 FUJIFILM Diosynth Biotechnologies call Genki.

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 smalltown life and the convenience of living close to the vibrant pulse of big cities. Eightyseven percent of Texas population lives within a 180mile 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.

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&IDs 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:

• Masters Degree with 2 years of experience in Pharmaceutical or other regulated Industry; OR
• Bachelors degree with 3 years of experience in Pharmaceutical or other regulated Industry; OR
• Associates 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 TOPs 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.

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 handeye 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.

Join us! FDB is advancing tomorrows medicine impassioning employees to chase the impossible and continually expand their potential. We are a company of emboldened goal seekers driven by an innate desire to better ourselves our families our workplace our company our community and the world at large.

To all agencies: Please no phone calls or emails to any employee of FUJIFILM about this requisition. All resumes submitted by search firms/employment agencies to any employee at FUJIFILM viaemail the internet or in any form and/or method will be deemed the sole property of FUJIFILM unless such search firms/employment agencies were engaged by FUJIFILM for this requisition and a valid agreement with FUJIFILM is in place. In the event a candidate who was submitted outside of the FUJIFILM agency engagement process is hired no fee or payment of any kind will be paid.

Fujifilm is committedto providing equal opportunities in hiring promotion and advancement compensation benefits and training regardless of nationality age gender sexual orientation or gender identity race ethnicity religion political creed ideology national or social origin disability veteran status etc.

If you require reasonable accommodation in completing this application interviewing completing any preemployment testing or otherwise participating in the employee selection process please direct your inquiries to our HR Department or.