Summary: The Manufacturing Compliance Coordinator II assists with 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.
Responsible for participating in the following activities within the Manufacturing Support Services function:
- Work collaboratively with site management to instill a ‘Quality Culture' by coaching Manufacturing staff in the application of GMP Principles including the underlying rational of those principles.
- Support the Quality and Manufacturing organization during internal and supplier audits
- Support the external and internal Audit Programs to be in an acceptable state of compliance
- Work with Quality management to implement quality systems that will enable cGMP manufacturing of pre-clinical to commercial products
- Responsible for Manufacturing audit preparations, conducting internal audits, assisting client audits with site documentation collation
- 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 Root Cause Analysis Investigations
- 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:
- Excellent oral and written communication skills, interpersonal and organizational skills.
- Excellent organizational, analytical, data review and report writing 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.
- Ability to multitask and easily prioritize work.
- Ability to work independently with little supervision.
- 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.
- Bachelor's Degree and four (4) years' experience in Quality Assurance or GMP Compliance role supporting pharmaceutical, biopharmaceutical or biotechnology products; OR
- Associate degree and six (6) years' experience in Quality Assurance or GMP Compliance role supporting pharmaceutical, biopharmaceutical or biotechnology products; OR
- High School Diploma or GED and eight (8) years' experience in Quality Assurance or GMP Compliance role supporting pharmaceutical, biopharmaceutical or biotechnology products
- Experience with cell culture and purification processes
- Experience authoring CAPAs, change controls, and deviations
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 e-mail FDBTHR@fujifilm.com or call 979-431-3500.