Nature and ScopeThis position is responsible for ensuring the overall quality in their assigned areas through the execution of site policies and procedures, programs and work instructions. Ensures all processes and products meet specifications and that products are produced in accordance with GMP requirements. This position requires working closely with other departments on production issues/situations, product dispositions and investigations into root causes for deficiencies.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.For New Albany Facility Only - Conduct and calculate accurate packaging AQL Inspections.For New Albany Facility Only - Verify Packaging Bill of Materials for correct components used.For New Albany Facility Only - Maintain changes made to Challenge Sets and any Inspection Qualification sets as required.For New Albany Facility Only - Maintain the Particulate Program, reporting data surrounding defects as found during the inspection process, including communication with the New York Laboratory and sample shipments.For New Albany Facility Only - Conduct daily Building Automation System (BAS) monitoring, ensuring escalation, as required.For Hilliard Facility Only - Conduct component and raw material receipt.For Hilliard Facility Only - Conduct monthly review of the Building Automation System (BAS), ensuring escalation, as required.Achieve and maintain all required equipment and/or room clearance qualifications.Conduct accurate verifications and checks as well as accurate process inspections.Identify out of specification product, ensuring segregation and escalation, as required.Ensure errors and omissions are resolved according to Standard Operating Procedure (SOP) requirements, providing guidance to plant personnel with documentation inquiries, corrections, and investigations.Ensure all work is performed and documented in accordance with existing Company policies and procedures, as well as cGMP, health, and safety requirements.Conduct daily environmental chart monitoring, ensuring escalation, as required.Support finished and in-process product shipping activities and perform quality related oversight and verifications.Generate controlled documents such as logbooks and labels.Achieve and maintain all required gown qualifications.Perform room, area and equipment clearances.Participate in Media Fill and maintain qualification.Partner with other departments to implement timely procedural changes and resolve compliance issues.Able to conduct investigations and continuous quality improvement initiatives (such as CAPAs) with minimal supervision. Able to generate reports that describe these activities.Able to implement regulatory documents and apply them to non-routine issues.Able to mentor other QA Operations associates.Able to perform all tasks with minimal error rate.Perform any other tasks/duties as assigned by management.Basic knowledge and application of cGMPs and supporting regulatory documents.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. Associates or Bachelor's Degree preferred.At least two (2) years of related experience (QA, Compliance, Auditing, Laboratory or Inspection) within a GMP environment is required.Experience in QA working in a cGMP manufacturing environment is required.Working knowledge and understanding of quality assurance principles and familiarity with QA programs.Strong analytical skills, attention to de