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Associate II, Quality Control Raw Materials

Company: TissueTech Inc
Location: Miami
Posted on: May 16, 2022

Job Description:

Job DescriptionJob Description:The Quality Control Raw Materials Associate II is responsible for contributing to key functional, tactical, strategic and operational aspects of the Quality Control Raw Materials group at the Tissue Tech Doral Manufacturing site.Responsibilities:

  • Supports GMP production by sampling and testing of various raw materials used in pharmaceutical manufacturing.
  • Performing incoming sampling and inspections for various raw materials.
  • Their own training on all necessary documentation for CGMP compliance, sampling/inspection support for raw materials, container closures, and packaging components, while maintaining, robust and compliant cGMP documentation practices.
  • Entering data into inventory control systems, maintaining retention (retain) samples, and completing all training/course requirements while maintaining 100% compliance on all assignments.
  • Interfaces with QC Analytical, Donor Eligibility, Warehouse, and Manufacturing internal customers.
  • May also support the Supervisor/Manager for activities related to compliance with GMP and identifying corrective actions.
  • Be able to work effectively both independently and within a team framework, requiring both robust written and verbal communication skills.
  • May perform(s) complex and routine laboratory activities in support of GMP Raw Materials testing.
  • Performs laboratory maintenance activities, including the monitoring of supply inventories and equipment calibration status.
  • Performs initial assembly of lot file documentation; verifies required testing.
  • Documents sample chain of custody information.
  • Be able to work effectively both independently and within a team framework, requiring both robust written and verbal communication skills.
  • Participates in QC Raw Material method troubleshooting and in investigations of OOS result(s).
  • Supports the organization in maintaining a work environment focused on quality and that fosters learning, respect, open communication, collaboration, integration, and teamwork.
  • Other duties as assigned.Knowledge, Skills & Abilities
    • Minimum Bachelor's Degree in a scientific field
    • 2 years GMP laboratory experience at a minimum.
    • Experience with compendial testing of raw materials for pharmaceutical production preferred
    • Communication skills with the ability to communicate scientific work performed to the team.
    • Proficiency with MS Excel and Word
    • Legible penmanshipEducation /Experience
      • B.S Chemistry or related discipline (biochemistry, microbiology and biology)
      • Equivalent education and experience may substitute for stated requirements#LI-RM1 Physical Requirements:• Must be able to move 50 lbs. with assistance of equipment.

Keywords: TissueTech Inc, Miami , Associate II, Quality Control Raw Materials, Other , Miami, Florida

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