Manufacturing Compliance Specialist - Weekend Day Shift

Durham, North Carolina

Employer: Biomerieux
Industry: Manufacturing
Salary: Competitive
Job type: Full-Time
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:
  • 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
Created: 2024-10-06
Reference: 49544
Country: United States
State: North Carolina
City: Durham
ZIP: 27703

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