Manager, Manufacturing Compliance

Paragon Bioservices   •  

Baltimore, MD

8 - 10 years

Posted 238 days ago

This job is no longer available.

Key Responsibilities:

  • Management of the compliance function and team for GMP manufacturing compliance
  • Responsible for ensuring documentation including batch records, SOPs, logbooks, etc. that will be used throughout the manufacturing facility
  • Adheres to internal/external guidelines, specifications, and regulatory requirements while creating and maintaining documentation
  • Ensures that SOPs relevant to documentation (batch records, logbooks, etc.) are generated, maintained and available
  • Tracks GMP review and production close out of batch record documentation
  • Key contact with Quality Assurance to ensure robust and stable document flow from issuance to archiving
  • Positively interacts with internal associates to quickly and effectively resolve issues
  • Addresses deficiencies and ensures completion of all follow-up actions, specifically those that target process fixes to maintain consistent resolutions to all batch review issues according to GMP standards and company objectives
  • Supports implementation of CAPAs, SOP revisions, quality improvement initiatives, operational excellence projects, etc.
  • Develops processes for batch records including for issuing, tracking and reviewing batch records
  • Develops and maintains metrics to track batch record turnaround time, errors and document related deviations

Education / Experience:

  • Bachelor’s degree in Chemistry, Life Science or Engineering field
  • 8+ years of broad cGMP production experience, with knowledge and understanding of process, documentation requirements and activities, preferably in an biologics manufacturing environment
  • 3 years in a leadership role
  • Extensive experience with GMP documentation management

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