QA Specialist II Data Integrity

A proactive and driven team player is required to passionately support delivery and embedding of the Data Integrity projects at FDBT. The Quality Assurance (QA) Specialist II for Data Integrity will be responsible for the day to day running of the FDBT Data Integrity Program performing data integrity assessments gap confirmation and risk assessments generate remediation plans and categorize gaps based on business priority and risks.

Reports to Senior Director 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:

• Work collaboratively with all levels of the FDBT site to instill a Quality Culture by coaching in the application of GMP Principles including the underlying rational of those principles.
• Act as an ambassador for FDBT Quality Culture.
• Deputize fronting Data Integrity in customer and regulatory audits (as required).
• Work with Quality management to implement quality systems that will enable cGMP manufacturing of preclinical to commercial products.
• Work as a change agent to compliantly improve existing or introduce new ways of working.
• Strong experience with GMP manufacturing processes quality and regulatory requirements.
• Ensure smooth operation of the FDBT Data Integrity program highlighting any issues in a timely manner.
• Provide guidance and advice to ensure Data Integrity remediation actions are successfully completed.
• Provide coaching and training for staff in Data Integrity Principles.
• Engage in global FDB projects and meetings to include being an active participant in work groups and assessment of existing and new global systems.
• Schedule and perform assessments gap confirmation and schedule stakeholder followup.
• Review prepurchase of systems and analyze to ensure Data Integrity Compliance.
• Draft FMEAs and lead stakeholder meetings.
• Raise and manage change controls and CAPAs and drive mitigation and remediation.
• All other duties as assigned.

Qualifications:

• Bachelors degree in a related science concentration with 2 years of experience of cGMP supporting pharmaceutical or biotechnology products; OR 1 year experience with FDB with a related role.
• Associates degree in a related science concentration with 4 years of experience in a regulated industry including 2 years of experience of cGMP supporting pharmaceutical or biotechnology products; OR
• High School or equivalent and 6 years of experience of cGMP supporting pharmaceutical or biotechnology products.
• Involvement in Data Integrity projects during previous roles preferred.
• Ability to collaborate effectively with stakeholders from across the business at all levels.
• Excellent written and oral communication skills.
• Excellent organizational analytical data review and report writing skills.
• Motivated cross functional worker.
• Ability to set and achieve personal performance goals.
• Provide input to departmental objectives.
• Strong understanding of 21 CFR Part 11 and Annex 11 regulations FDA GMP GAMP and 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.
• Ability to work weekends and offshift hours as needed to support manufacturing activities.
• 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.