Position Summary: Normal working hours for this role are anticipated to be Friday - Sunday 7:00am - 7:30pm. The Manufacturing Compliance Specialist will focus on Right First Time (RFT) initiatives + Review of manufacturing documentation for compliance to GDP and CPP prior to submission to QA + Provide on the floor document review of batch records and support for Manufacturing teams + Evaluate trend data for process improvement + Deliver training to manufacturing teams on SOP/Process changes + Execute document and process improvement changes + Track and Trend RFT metrics Primary Responsibilities: + Perform review of Manufacturing Documentation across multiple production lines + Ensure all Manufacturing Documents are fully reviewed before submission to the Batch Release Group + Provide on the floor document review and recommendations for error corrections + Support manufacturing teams to provide feedback on error trends and area of focus + Record and maintain data to track batch record turnaround time, errors and document related deviations + Track training activities and curriculums to ensure compliance is consistently maintained + Partner with Training, Industrialization, Engineering, Quality, Supply Chain and Manufacturing departments to provide detailed training on SOP and process changes to ensure compliance + Provide improvement ideas on documentation and processes + Complete change control to ensure that improvement ideas are fully implemented. + Partner with the investigation team to promote timely correction and closure of Non-Conformances + Perform any additional job related duties as requested Education, Skills, & Experience: + HS diploma/GED and a minimum of 4 years experience in a regulated production/operations environment + Associate degree (or higher) & 2 years experience in a regulated production/operations environment + Experience in FDA regulated environment with knowledge of Good Manufacturing Practices + Experience in Batch Record review in a regulated production/operations environment + Experience in continuous improvement, project management and delivering of training preferred + Ability to translate written instructions, work orders and specifications. + Knowledge of FDA and/or GMP regulations required + Quality documentation review in production facility preferred. + Excellent interpersonal skills and ability to work with all levels of an organization + Ability to work effectively and efficiently toward goal completion in a complex, diverse environment with multiple and changing demands + Must be able to work effectively in a team based and individual environment. + Must be able to deliver negative and positive feedback effectively. + Must hold to the highest level of accountability and integrity + Knowledge of Microsoft Word, Excel, PowerPoint and Outlook required. + SAP experience preferred + Strong analytical and problem-solving skills. + Leadership experience preferred #biojobs