1st Shift Review/Release I

The Quality Compliance Review/Release I position will be responsible for the day-to-day review of bulk and/or Finished Goods (FG) batch record documentation and release of bulk and FG to ensure they meet the high-quality standards set by management, customers, and regulatory requirements. They will work cross-functionally with Production and Manufacturing to ensure that specifications are being met. This position must be detail-oriented.

Requirements

• Ensure SOPs are followed to meet and exceed quality standards set forth in specifications.
• Collaborate and communicate with upper management and Operations.
• Review batch documentation to ensure appropriate processes are being followed and documented.
• Release of batches in a highly-regulated environment.
• Review all documentation and have corrections made by the personnel who generated the documentation non-conformance.
• Enter Production KPI information, as appropriate.
• Ensure records are GMP-compliant as required by SOPs, methods, or regulations.
• Ensure GDP is followed on all applicable batch documentation.
• Support the company mission, values, and standards of ethics and integrity by incorporating these into the development and implementation of business plans.
• Participate in the generation of Annual Product Reviews (APRs) of OTC products.
• Own and lead special projects as assigned.
• Perform all other assigned duties as required by Quality Management.