Facilities Compliance Specialist
4 weeks ago
The Facilities Compliance Coordinator II will be responsible for performing various aspects of tracking, coordination, and closure of CAPAs, change controls and deviations, and assists in supporting the timely release and disposition of batches and other post-execution activities.
Key Responsibilities:
- Collaborate with site management to instill a 'Quality Culture' by coaching Facilities staff in the application of GMP Principles.
- Support the Quality and Facilities organization during internal and supplier audits.
- Ensure the external and internal Audit Programs are in an acceptable state of compliance.
- Implement quality systems that will enable cGMP manufacturing of pre-clinical to commercial products.
- Prepare Facilities for audits, assist with client audits, and collate site documentation.
- Coordinate the initiation of new deviations.
- Lead deviation investigation, CAPA, and required cGMP documentation for Facilities.
- Lead Root Cause Analysis Investigations.
- Lead Problem Analysis (PA) events.
- Lead After Action Reviews (AAR).
- Schedule and facilitate lessons learned.
- Complete periodic reviews.
- Provide and maintain metrics around batch closure, including deviation, CAPA and change control status.
- Manage documents required for deviations, CAPA and Change controls.
- Perform Facilities Trend Analysis.
Requirements:
- 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
Preferred Qualifications:
- Experience with critical utilities, pest control, facilities, cell culture and purification processes
- Experience authoring CAPAs, change controls, and deviations
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