Job Title

ATTENTION MILITARY AFFILIATED JOB SEEKERS, - Our organization works with partner companies to source qualified talent for their open roles. The following position is available to, Veterans, Transitioning Military, National Guard and Reserve Members, Military Spouses, Wounded Warriors, and their Caregivers. If you have the required skill set, education requirements, and experience, please click the submit button and follow the next steps.Nature and ScopeThis position is responsible for providing the Quality Assurance review associated with the manufacture of safe, pure, effective, and sterile pharmaceuticals in accordance with company Standard Operating Procedures (SOPs), policies and current Good Manufacturing Procedures. , The Batch Record reviewer ensures all documentation, processes and products meet specifications and that Batch Records are completed in accordance with GMP requirements. , This position requires effective collaboration with other departments on production issues/situations, product dispositions and investigations. , The Batch Record reviewer works under the direct supervision of the QA Supervisor.Essential Duties and ResponsibilitiesNothing in this job description restricts managementâs right to assign or reassign duties and responsibilities to this job at any time.Execute timely reviews all batch documentation for accuracy and completeness according to cGMPâs.Execute batch record review and review of supporting systems including Veeva Vault and Trackwise.Adheres to internal and external guidelines, specifications and regulatory requirements while reviewing batch documentation.Ensures all work in performed and documented in accordance with existing company policies and procedures, as well as cGMP and health and safety requirements.Work with area personnel to resolve errors and/or discrepancies.Assures all errors and corrections are resolved according to SOP requirements.Enter data into applicable spreadsheets/databases.Update metric reporting as needed.Submit error free batch records to release for product shipments.Execute batch record review of Media Fills and Research and Development (R,D) batches.Review and approve preliminary batch records after batch record assembly.Review logbooks for accuracy after creation.At any time may be required to perform the job responsibilities for the Documentation Specialist.Perform any other tasks/duties as assigned by management.