QA Supervisor, Document Control

Overview

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.

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 small-town life and the convenience of living close to the vibrant pulse of big cities. Eighty-seven percent of Texas' population lives within a 180-mile 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.

Summary: The Quality Assurance Supervisor, Document Control will be responsible for assisting in leading the QADC team with the management, metrics, and closure of Change Controls. The Supervisor will handle all associated responsibilities in compliance with Fujifilm quality policies and site SOPs to ensure regulatory compliance.

External US

Essential Functions:

• Leadership
• Mentors and provides leadership to the QA compliance team to ensure it is complying with local and global quality standards, regulatory requirements and partner commitments.
• Develop, motivate and lead team towards achieving organizational and individual goals.
• Work collaboratively with management of other site functions to instill a 'Quality Culture' by coaching in the application of GMP Principles including the underlying rational of those principles.
• Write performance reviews for direct reports.
• Compliance Delivery
• Demonstrates QA leadership and support to the organization in processing Change Control records, to be compliant and on-time.
• Possesses understanding of production platforms utilized by Fujifilm Texas.
• Possesses the ability to understand complex work and submit a strategy, to staff, for completing their work, as related to change control.
• Has knowledge of global computer systems as related to impact of system changes.
• Has knowledge of engineering principals, documentation related to project execution strategies.
• Understands validation strategies related to effectiveness monitoring of facility and operational change.
• Deliver metrics for understanding process performance and improvement opportunities.
• New Business Growth
• Support client due diligence and Quality audits as well as regulatory inspections.
• Work with Quality management to implement and grow phase-appropriate quality systems that will enable cGMP manufacturing of pre-clinical to commercial products.
• Compliance
• Ensure self, and team, have no overdue training, or site actions. Support other QA teams and other functions in completion of site actions.
• Provide cGMP guidance to other functions such as Manufacturing, Facilities and QC.
• Utilize investigative techniques to assist deviation owners to determine root causes of deviations and proper corrective and preventative actions.
• Review and/or approve basic and technical documentation to include, but not limited to
• Deviation Reports, Corrective Action/Preventive Action Plans and Change Controls
• Promptly notify Senior Management of potential quality or regulatory issues that may affect product quality or regulatory compliance.
• Perform other duties as assigned.

Required Skills & Abilities:

• 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.
• 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.

Qualifications:

• Master's degree in a science-related field with three (3) years of related experience; OR
• Bachelor's degree in a science-related field with five (5) years of related experience; OR
• Associate's degree in a science-related field with seven (7) years of related experience; OR
• High School Diploma or GED with nine (9) years of related experience.
• At least two (2) years of prior supervisory or lead experience.
• At least two (2) years of cGMP experience.

Preferred Qualifications:

• Certified Quality Auditor
• Degree in Biology, Chemistry or Engineering

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.

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 via-email, 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.