drjobs Senior Manufacturing Compliance Specialist

Senior Manufacturing Compliance Specialist

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Job Location drjobs

College Station, TX - USA

Monthly Salary drjobs

Not Disclosed

drjobs

Salary Not Disclosed

Vacancy

1 Vacancy

Job Description

Position Overview

The Senior Compliance Specialist owns all manufacturing CAPAs change controls and deviations. Leading all manufacturing deviation investigations through to completion. Support all internal and external audits. Work collaboratively with cross functional groups including Quality Assurance to support ontime release and disposition of batches and other postexecution activities.

Company Overview

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.

Job Description

Essential Functions:

Responsible for 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

  • Lead deviation CAPA and change control closure for Manufacturing
  • Leads review of quality events and initiation of new deviations as required
  • Lead initiation of New Product Introduction change controls
  • Lead Root Cause Analysis Investigations
  • Lead Problem Analysis (PA) events
  • Lead After Action Reviews (AAR)
  • Lead the completion of Periodic Reviews
  • Lead Internal and External Audit readiness coordination and response.
  • Support Compliance Coordinators with the coordination of batch and formulation record review and corrections to executed records
  • Support Compliance Coordinators with continuous improvement of batch related documentation
  • Supports coordination of deviation workload within the Manufacturing Compliance Coordination group
  • Support the generation and maintenance of metrics around batch closure including deviation CAPA and change control status
  • Support Compliance Coordinators to aid 100 ontime closure of all quality related investigations
  • Provides training and support to the Compliance Coordinators
  • Provides training and support to the Deviation Coordinators

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.
  • Ensures all equipment is scheduled for routine maintenance and calibration and provide metrics for executed work.
  • Work directly with the Facilities group to plan and support any onsite vendor support/maintenance activitiesincluding escorting onsite visitor requirementsensuring all visitors are registered for proper access on the equipment.
  • Ensure all equipment utilized on the floor for manufacturing is entered correctly into the Building Management System and has accurate and effective preventative maintenance activities.
  • Point of contact for client and regulatory inspection support with trends and metrics for all manufacturing equipment with respect to maintenance and lifecycle.
  • Maintains the schedule for planned downtime for all manufacturing equipment and provides metrics for equipment up/down time.
  • Leads the facility shutdown planning and associated change controls with respect to manufacturing equipment and facilities and provides metrics for all facility related change controls.
  • Leads the Production Floor GEMBA walks to identify any issues/problems that need addressing to remain in compliance and provides metrics for common themes and any trends that may occur.
  • Ensures routine walk throughs of the facility are completed and work orders for items found have been submitted. Also provides metrics for items found to identify and trends that may occur.
  • All other duties as assigned.

Required Skills & Abilities:

  • Must have a working knowledge of cGMP regulations associated to production of biologic drug products
  • Excellent oral and written communication skills interpersonal and organizational skills
  • Excellent organizational analytical data review and report writing skills
  • Thorough understanding of all aspects related to cGMP manufacturing
  • Thorough understanding of SingleUse Technology used in bioprocessing (downstream and/or upstream)
  • Thorough understanding of closure requirements associated to working in a Ballroom manufacturing facility
  • Proficient user of deviation management systems such as TrackWise
  • Proficient user of quality document control systems such as MasterControl
  • Proficient with Microsoft Office applications
  • Good selfdiscipline and attention to detail
  • Must have flexible work hours must be willing to work outside of normallyscheduled hours as necessary; including opportunities for alternative shifthours and weekends as required
  • Ability to multitask and easily prioritize work
  • Ability to work independently with little supervision
  • Must have good planning skills and must be willing to interface colleagues across all levels of the FDB network

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 handeye 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:

  • Bachelors Degree and five 5 years experience in pharmaceutical or other regulated industry preferably in Quality Assurance or compliance role; OR
  • Associate degree and seven 7 years experience in pharmaceutical or other regulated industry preferably in Quality Assurance or compliance role ;OR
  • High School Diploma or GED and nine 9 years experience in pharmaceutical or other regulated industry preferably in Quality Assurance or compliance role.

Preferred Qualifications:

  • Experience with cell culture and purification processes
  • Experience leading teams

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.

EEO Information

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.

ADA Information

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.


Required Experience:

Senior IC

Employment Type

Unclear

Company Industry

Department / Functional Area

Manufacturing

About Company

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