Nature and ScopeThis position is member of the Quality Assurance (QA) Batch Record Review Group. The QA Batch Record Reviewer III 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 Practices (cGMPs).The Batch Record Review group provides support to other departments as needed and is critical in maintaining product release schedules and meeting company goals. The quality review of the batch record includes the correction and approval of batch record documentation. The position requires collaborating with multiple departments regarding metrics, exception reporting and knowledge of regulatory documents and cGMPs. This position includes travel between the American Regent facilities.Essential Duties and ResponsibilitiesNothing in this job description restricts management's right to assign or reassign duties and responsibilities to this job at any time.Perform critical review of executed batch record documentation.Enter data into applicable spreadsheets/databases.Ensure all work is performed and documented in accordance with existing Company policies and procedures, in accordance with Code of Federal Regulations, and mutually recognized agreements with international regulatory bodies as well as and health and safety requirements.Work with personnel to assure that all errors and corrections are resolved according to SOP requirements.Provides guidance for plant personnel on batch record corrections.Submit error free batch records for product shipment.Demonstrated ability to implement regulatory documents.Able to evaluate non-routine data and communicate conclusions.Update metric reports for trending.Evaluate metrics for trending and cost improvement.Identify quality process improvements to increase quality and efficiencies in systems, operations, and personnel.Mentors and provides guidance for less senior QA Batch Record Review Associates.Submit Change Requests as needed.Represents the batch record review group at cross-functional meetings.Support investigations and Corrective Actions/Preventative Actions (CAPAs), including report writing.Assists resolving quality issues in conjunction with the senior QA staff including deviations, memos, investigations and CAPAs. Able to generate final reports with minimal supervision.Perform any other tasks/duties as assigned by management.Education Requirements and QualificationsTo perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill and/or ability required.High School Diploma or GED equivalent required. Associate or bachelor's Degree preferred.Minimum of three years' equivalent experience with cGMP batch record documentation required.Must have QA, Compliance and Auditing experience working in a cGMP manufacturing environment.Strong attention to detail and adherence to SOPs.Intermediate skills in Microsoft Word and Excel are required.Strong ability to develop metrics and perform trend analysis.Excellent organizational, interpersonal and communication skills (written and oral) required.Demonstrable analytical thinking and problem-solving skills.Demonstrated success in managing multiple activities at the same time, producing outstanding results.Ability to meet and maintain clean gowning requirements is preferred.Ability to take feedback constructively and function in a team-oriented work environment.Ability to work overtime as needed.Physical Environment and RequirementsEmployee must be able to occasionally lift and/or move up to 25 pounds.American Regent celebrates diversity and we are comm