QA Batch Record Review I

Nature and ScopeThis position is member of the Quality Assurance (QA) Batch Record Review Group. The QA Batch Record Reviewer I 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.Performs a critical review of the executed batch record documentation.Work with 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 reports for trending.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.Submit error free batch records for product release.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 one year of prior work experience and/or transferable skills is required.Experience in QA, Compliance, Auditing in a cGMP manufacturing environment is preferred.Skills in Microsoft Word and Excel are required.Excellent organizational, interpersonal and communication skills (written and oral) required.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 committed to creating an inclusive environment for all employees. We are an Equal Opportunity Employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability status, or protected veteran status.Applicants have rights under Federal Employment Laws.FMLA poster: https://www.dol.gov/whd/regs/compliance/posters/fmlaen.pdfKnow Your Rights: Know Your Rights: Workplace discrimination is illegal (eeoc.gov)Employee Polygraph Protection Act: https://www.dol.gov/whd/regs/compliance/posters/eppac.pdfAmerican Regent Inc. endeavors to make https://americanregent.com/Careers accessible to any and all users. If you would like to contact us regarding the accessibility of our website or need assistance completing the application process, please email hrtalentacquisition@americanregent.com.