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Manufacturing Compliance Specialist
4 weeks ago
Summary:
The Manufacturing Compliance Specialist is responsible for manufacturing quality deliverables such as deviation investigations, trend assessments, CAPA, batch record review, and change controls. Additionally, the Manufacturing Compliance Specialist serves as a mentor to members of the operations team, providing training and guidance for compliance related activities.
Duties And Responsibilities:
• Primary driver of Manufacturing investigations for related non-conformances.
• Primary driver for Manufacturing change control requests
• Primary Driver for GMP audit responses / CAPA development.
• Reviewing of Manufacturing batch records and logbooks
• Championing the Inventprise quality philosophy.
• Tracking and reporting KPIs; and driving continuous improvement efforts.
• Identifying and mitigating risks in manufacturing operations that could negatively impact delivery of safe and effective products.
• Assistance with inspection readiness efforts and providing Inspection support as required.
• Build partnerships with cross functional department teams.
• Provide critical communications upward, downward, and across as deemed fit; manage compliance related decisions– acquire feedback, input, and consult as required.
• Review and approve documents, including standard operating procedures, batch records, material specifications, and validation protocols / reports.
• Ensure deviations, CAPA, change controls, and other business drivers are supported and completed in a timely fashion.
• Driving right first time (RFT) culture within Manufacturing.
Education:
Bachelor’s degree in related field is preferred. Minimum of associate’s degree and/or equivalent combination of education and experience is required.
Experience:
• 2+ years of experience in a GMP Quality or Manufacturing setting.
• Extensive knowledge of SOPs and cGMPs and the know–how to work and manage within a regulated environment.
• Experience working in a QMS
• Adaptable to a fast paced, complex, and ever-changing business environment.
Working Conditions:
• Typing and computer use for extended periods
• Must be able to sit/ stand for extended periods of time.
• Minimal work in areas that may have strong magnets.
• Must be able to occasionally work in a cleanroom environment that requires gowning.
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