POSITION OVERVIEW

This position is responsible for ensuring that batch record reviews and product releases are completed and communicated, including reviewing and interpreting of laboratory results to ensure criteria are met. The Batch Release Specialist will support Belmar Pharma Solutions in carrying out the mission of the company.

• Responsible for all batch record reviews and batch release activities and providing batch release associated communication to all relevant departments as applicable.?
• Review all lab results to ensure all Quality criteria are met for all batches.?
• Applies current Good Manufacturing Practice (cGMP) and Good Documentation Practice (cGDP) requirements, guidelines and practices.?
• Review and approve primary product labels and in process labels for accuracy?and legibility.
• Review and approve sterile load documentation and applicable calculations.
• Attend and/or lead all required meetings and provide clear, professional verbal and email communications.??
• Author and/or initiate deviations as appropriate.
• Provide cGDP training as needed.
• Manage batch release schedule and provide updates as needed.
• Must be able to read, understand SOPs and all guidelines as they relate to the process?
• Gowning for ISO classified cleanroom area may be required as part of training or special project.?
• Must be able to work in a variety of positions and locations such as sitting, standing, squatting, kneeling, reaching, and walking, for prolonged periods of time.?
• Must be able to use necessary equipment such as computers, scanners, printers, phone/headset, or other technology devices as assigned?(data entry, Microsoft Office products, email, internet, and other software or technology devices as assigned)?
• Special projects and other duties as assigned by Management.