Manufacturing Compliance Coordinator I

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 :

Work collaboratively with staff and management of site functions to instill a Quality Culture’ by coaching in the application of GMP Principles including the underlying rational of those principles.

Compliance

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

Deviation Investigation

• Participate and support investigations for deviations and events.
• Participate in investigations and assist in identification of root and / or contributing causes.
• Ensures required Management and Quality approvals on final investigations while satisfying established due dates. Facilitates corrective and preventive action agreement with stakeholders.
• Support client due diligence and Quality audits as well as regulatory inspections.
• Promptly notify Management of potential quality or regulatory issues that may affect product quality or regulatory compliance.

Equipment Compliance Coordination

• Is the Primary Point of Contact for any equipment related servicing and or Out of Service requests.
• Support the routine maintenance and calibration of manufacturing equipment by the monitoring and scheduling of any preventative or corrective work required.
• Work directly with the Facilities group to plan and support any on-site vendor support / maintenance activities including escorting on-site visitor requirements and support any specific access requirements needed.
• Support the entry of any required equipment specifications or requirements into the site maintenance and equipment control application.
• Provide client and regulatory inspection support with trends and metrics.
• Provide input on scheduling of down-time for all manufacturing equipment.
• Assists with facility shutdown planning and associated change controls with respect to manufacturing equipment and facilities.
• Assists with Production Floor GEMBA walks to identify any issues / problems that need addressing to remain in compliance.
• Perform routine walk throughs of the facility and submit any work orders for items found.
• All other duties as assigned.

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 of experience in pharmaceutical or other regulated industry, preferably in Quality Assurance or compliance.
• Associate’s degree and four (4) years of related experience in pharmaceutical or other regulated industry, preferably in Quality Assurance or compliance.
• High School Diploma or GED and six (6) years’ experience in pharmaceutical or other regulated industry, preferably in Quality Assurance or compliance.

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

[email protected]

or call

979-431-3500