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 pre-clinical 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 follow-up.
Review pre-purchase 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:
Bachelor's 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.
Associate's 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 ISPE.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 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.
Ability to work weekends and off-shift hours, as needed to support manufacturing activities.
Must be willing to travel occasionally, as needed.
Attendance is mandatory.
Join us! FDB is advancing tomorrow's 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.
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 979-431-3500.