Position Summary :
Normal working hours for this role are anticipated to be Sunday - Thursday 11 : 00pm - 7 : 30am.
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 linesEnsure all Manufacturing Documents are fully reviewed before submission to the Batch Release Group
Provide on the floor document review and recommendations for error correctionsSupport manufacturing teams to provide feedback on error trends and area of focusRecord and maintain data to track batch record turnaround time, errors and document related deviations
Track training activities and curriculums to ensure compliance is consistently maintainedPartner with Training, Industrialization, Engineering, Quality, Supply Chain and Manufacturing departments to provide detailed training on SOP and process changes to ensure complianceProvide 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-ConformancesPerform any additional job related duties as requestedEducation, Skills, & Experience :
HS diploma / GED and a minimum of 4 years experience in a regulated production / operations environmentAssociate degree (or higher) & 2 years experience in a regulated production / operations environment
Experience in FDA regulated environment with knowledge of Good Manufacturing PracticesExperience in Batch Record review in a regulated production / operations environmentExperience in continuous improvement, project management and delivering of training preferredAbility 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 organizationAbility to work effectively and efficiently toward goal completion in a complex, diverse environment with multiple and changing demandsMust 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 integrityKnowledge of Microsoft Word, Excel, PowerPoint and Outlook required.SAP experience preferred
Strong analytical and problem-solving skills.Leadership experience preferredbiojobs
PandoLogic. Category : , Keywords : Regulatory Compliance Specialist
