Product Review Coordinator Iii, 2nd Shift (2pm -10: 30pm)

Job Description
Job Summary
This position will be responsible for reviewing finished product, semi-finished product, and compounding Batch Records for all products manufactured and/or packaged at the Waco facility ensuring compliance with Standard Operation Procedures and current Good Manufacturing Practices. This position is responsible for performing the Quality Assurance review of product records to support the final disposition process in Waco and coordinating training within the department. Responsible for the issuance of all batch related documents for manufacturing, production, validation, and quality assurance departments at the Waco facility with compliance to site Standard Operating Procedures and current Good Manufacturing Practices.
Job Details
This position is responsible for the following:
Real time Review and approval of records by QA on the shop floor. These records include but not limited to finished product, semi-finished product, and compounding Batch Records.
Understand cGMPs and procedural requirements for your area of responsibility and be a resource to operators and other personnel to ensure compliance to these requirements.
Make decisions consistent with job responsibilities, regulations, procedures and policies. Provide appropriate comments to cGMPs documents, when needed. Provide timely feedback and details to supervision and other impacted personnel.
Work together with Operations on resolving quality events on time.
Provide approval for re-work and in-process retest forms as well as any other supporting document that requires Quality signature.
As part of the batch review process perform continuous Gemba walks in the operation area.
Complete and conform to all training requirements for job role, including company-required and job role-specific training.
Carry out and assist in the on-going training of new and existing personnel, as appropriate.
Assess and understand events that may not be in accordance with procedures or cGMPs. Make decisions consistent with job.
Empowered to make Quality decisions.
Be part of Operation area T-2 meetings.
Participate and support OPEX initiatives and seek process innovation and continuous process improvement.
Reviews documents and collaborates with Production to identify defects and manufacturing trends.
Actively provides input and suggestions to help analyze and resolve Production problems.
Prepares required documentation regarding batch disposition to international sites as required.
Identifies and brings to resolution all batch record discrepancies to prevent a regulatory impact.
Performing the Quality Assurance Issuance of all batch related documents for manufacturing, production, validation, and quality assurance departments.
Issue batch records to support manufacturing and Production for the Waco facility ensuring accuracy, compliance, adherence to Data Integrity, and current Good Manufacturing Practices.
Issue PSO, Clinical Studies, Demonstration, and Validation Batch Records for Production use.
Assist Documentation Department to prepare, assign, and issue logbooks for the Waco facility.
Perform other duties as assigned