Production Compliance Specialist

3 days ago


Devens, Massachusetts, United States Omni Inclusive Full time
Job Summary

We are seeking a highly skilled Production Compliance Specialist to join our team at Omni Inclusive. As a key member of our compliance team, you will be responsible for ensuring that our production processes meet the highest standards of quality and regulatory compliance.

Key Responsibilities
  • Conduct and manage resolution of deviations, root cause investigations, impact assessments, and CAPAs as a Lead Investigator
  • Liaise with various groups and organizations as a Lead Investigator
  • Proactively identify and facilitate resolution of obstacles to timely completion
  • Proactively manage progression of investigation and CAPA to timely closure
  • Lead and participate in cross-functional investigation teams
  • Present investigation findings to key stakeholders and site management
Requirements
  • BS in chemical/biochemical engineering, biological sciences, or a related discipline with 1-3 years relevant experience
  • Prior experience in leading cGMP investigations utilizing formal Root Cause Analysis tools preferred
  • Demonstrated basic project management skills, including organization, collaboration, multi-tasking, and communication
  • Excellent verbal and written communication skills, including ability to present information clearly and concisely
  • Excellent interpersonal and collaboration skills necessary to interface with and influence all levels of the organization
  • Prior experience with SOPs, cGMPs, and knowledge of working within a regulatory environment
What We Offer

At Omni Inclusive, we offer a dynamic and supportive work environment, competitive compensation and benefits package, and opportunities for professional growth and development.



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