Quality Batch Release Supervisor

O pracovní pozici

The Batch Release Supervisor reports to the Director of Quality, and is responsible for leading, coordinating, and managing the batch release team. The Batch Release Supervisor will be the Subject Matter Expert (SME) for the batch release process and be able to provide support and or guidance within the department and throughout the company.

• Manage direct reports – Lead and coach team under direction of the Quality Director, driving a high-
performance organizational culture.
• Participate in routine batch release meetings and activities to prioritize batches requiring review for
quality batch release department based on supply needs.
• Monitor and report status of batches to key stakeholders, acting as a primary point of contact for
questions regarding status and priorities for the batch release department
• Ensures deviations are initiated for any batch record review related events.
• Effectively resolve documentation discrepancies and issues with operations and quality personnel in a
timely manner to allow for material release
• Participate in cross-functional teams to improve review efficiency and support
• Addresses deficiencies and ensures completion of all follow-up actions, specifically those that target
process fixes to maintain consistent resolutions to all batch review issues according to GMP
standards.
• Track monthly Batch Record related KPI’s and develop slides for the Site Monthly Dashboard.
• Review and approve manufacturing and analytical deviations, out of specification investigations and
material non-conformances. Compile data, prepare and review trends. Identify areas of concern and
communicate to management.
• Provide periodic updates at Manufacturing Team meetings to review current batch record errors to
improve performance.
• Train new manufacturing associates on batch record review
• Review and approve master and production batch records.
• Review and approve change control documents as it relates to batch records or the batch review
process.
• Review and approve standard operating procedures as it relates to batch records or the batch review
process.
• Maintain inspection ready procedures and participate in internal and customer audits and
inspections.


Vystupte z davu


• BS/BA degree in Biology, Chemistry, Biotechnology, or related field or an equivalent combination of
education and experience in a scientific or health-rated field

• Minimum 2 years directly related experience supporting compliance in a quality/compliance function
/applicable compliance field.

Co nabízíme

Fagron offers exciting opportunities for personal and professional growth. We provide an open and truly dynamic environment which supports and encourages you to develop your skills and talents.
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