Job Description

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.

Essential Functions:

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.

Compliance

• 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.
• Assists with leading Root Cause Analysis Investigations
• Assists with leading Problem Analysis (PA) events.
• Assists with leading After Action Reviews (AAR).
• Schedules and facilitates post manufacturing campaign lessons learned.
• Supports leading 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 complete any specific access required information.
• Ensure all equipment utilized on the floor for manufacturing execution is entered correctly into the Building Management System.
• Is the point of contact for client and regulatory inspection support with trends and metrics.
• Leads the input on scheduling of planned down-time for all manufacturing equipment.
• Leads the facility shutdown planning and associated change controls with respect to manufacturing equipment and facilities.
• Leads the Production Floor GEMBA walks to identify any issues/problems that need addressing to remain in compliance.
• Leads routine walk throughs of the facility and submit any work orders for items found.

All other duties as assigned.

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.

Qualifications:

• Bachelor’s Degree and four (4) years’ experience in pharmaceutical or other regulated industry, preferably in Quality Assurance or compliance role; OR
• Associate degree and six (6) years’ experience in pharmaceutical or other regulated industry, preferably in Quality Assurance or compliance role.; OR
• High School Diploma or GED and eight (8) 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 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.

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