Manufacturing Compliance Coordinator I
4 days ago
The Manufacturing Compliance Coordinator I plays a crucial role in ensuring the quality and compliance of our manufacturing processes. This position is responsible for tracking, coordinating, and closing Manufacturing CAPAs, change controls, and deviations, as well as assisting in the timely release and disposition of batches and other post-execution activities.
Key Responsibilities:
* Participate in the tracking and coordination of Manufacturing CAPAs, change controls, and deviations
* Assist in the timely release and disposition of batches and other post-execution activities
* Collaborate with staff and management to instill a Quality Culture by coaching in the application of GMP Principles
* Assist with deviation, CAPA, and change control closure for Manufacturing, including initiation of New Product Introduction change controls
* Participate in investigations and assist in identification of root and/or contributing causes
* Ensure required Management and Quality approvals on final investigations while satisfying established due dates
Requirements:
* 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
About Us:
FUJIFILM Holdings America Corporation is a leading provider of innovative solutions for the healthcare and life sciences industries. We are committed to advancing tomorrow's medicine and empowering our employees to chase the impossible. If you are a motivated and detail-oriented individual with a passion for quality and compliance, we encourage you to apply for this exciting opportunity.
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