Manufacturing Compliance Coordinator I - Fujifilm

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 Manufacturing Compliance Coordinator I leads the tracking, coordination, and closure of Manufacturing CAPAs, change controls and deviations, and assists in supporting the timely release and disposition of batches and other post-execution activities.

External US

Essential Functions:

Responsible for participating in the following activities within the Manufacturing Support Services function:

Compliance

• Coordinate batch and formulation record review and corrections to executed records.
• Coordinates the initiation of new deviations.
• Leads deviation, CAPA, and change control closure for Manufacturing, including initiation of New Product Introduction change controls.
• Leads Problem Analysis (PA) events.
• Leads After Action Reviews (AAR).
• Schedules and facilitates post manufacturing campaign lessons learned.
• Leads the completion of periodic reviews.
• Provides and maintains metrics around batch closure, including deviation, CAPA and change control status.

Required Skills & Abilities:

• Good oral and written communication skills, interpersonal and organizational skills.
• Practical understanding of equipment used in bioprocessing (downstream and/or upstream).
• Proficient with Microsoft Office applications.
• Good self-discipline and attention to detail.
• Must have flexible work hours – must be willing to work outside of normally-scheduled hours as necessary; including opportunities for alternative shift-hours and weekends as required.
• Experience working in cleanroom environments.
• Must have good planning skills and must be willing to interface with and support team members in many different roles and functions throughout the manufacturing facilities.

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, pushing, pulling, reaching above shoulders and stretching.
• Use hand-eye coordination and manual dexterity sufficient to operate a keyboard, photocopier, telephone, calculator, and other office equipment.
• Lift up to 25 pounds frequently and up to 50 pounds, on occasion.
• Attendance is mandatory.

Qualifications:

• Bachelor’s Degree with two (2) years related experience, preferably in biopharmaceutical manufacturing (GLP or GMP) or Quality Assurance.
• Associate degree and four (4) years of related experience preferably in biopharmaceutical manufacturing (GLP or GMP) or Quality Assurance.
• High School Diploma or GED and six (6) years’ experience preferably in biopharmaceutical manufacturing (GLP or GMP) or Quality Assurance.

Preferred Qualifications:

• Experience with cell culture and purification processes
• Experience authoring CAPAs, change controls, and deviations

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.