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Bulk Manufacturing - Validation

Company: The Autumn Group LLC
Location: Troy
Posted on: June 21, 2019

Job Description:

Summary: Validate/qualify equipment, systems, and processes in accordance with regulatory requirements and support, follow and implement company manufacturing standards policies and proceduresEssential Duties and Responsibilities include, but are not limited to, the following:

  • Generates, executes and/or reviews master and completed qualification and validation protocols, summary reports and associated data for conformance to regulations, SOPs, specifications and other applicable acceptance criteria
  • Analyzes the results of testing and determines the acceptability of results against pre-determined criteria.
  • Investigates and troubleshoots problems which occur and determines solutions or recommendations for changes and/or improvements.
  • Reviews, edits and approves deviation notifications, deviation investigations, and corrective actions.
  • Reviews, edits and approves change controls, SOPs, reports and other documentation
  • Coordinates with other departments or outside contractors/vendors to complete validation tasks.
  • Trains/advises less experienced Specialists.
  • Manages projects and prepares status reports.
  • May be required to oversee contingent workers.
  • Other duties assigned by management. Knowledge Skills & Abilities:
    • Ability to maintain integrity and honesty at all times
    • Ability to work independently or as part of a team
    • Ability to communicate with transparency
    • Continuously drive to improve processes for improved performance
    • Demonstrate respectful behavior at all times
    • Basic working knowledge of Microsoft Suite (Word, Excel, Powerpoint)
    • Gathers and organizes information
    • Meets commitments on time
    • Follows directions; performs well-defined tasks
    • Effective time management skills
    • Seeks to identify continuous improvement needs Education and Experience:
      • BS/BA in Engineering, Chemistry, or Life Sciences with 0-2+ years of related experience within the field preferred; may substitute relevant experience for education. For more jobs like this please visit or

Keywords: The Autumn Group LLC, Worcester , Bulk Manufacturing - Validation, Other , Troy, Massachusetts

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