What are the responsibilities and job description for the Manufacturing Compliance Specialist - Weekend Day Shift position at bioMerieux SA?
Description
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:
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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
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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
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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:
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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
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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
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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
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Knowledge of Microsoft Word, Excel, PowerPoint and Outlook required.
- SAP experience preferred
- Strong analytical and problem-solving skills.
- Leadership experience preferred
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