QA Operations Materials Associate

American Regent, Inc.-posted 2 months ago
New Albany, OH
501-1,000 employees
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This position is a member of the Quality Assurance team. This position is responsible for ensuring the overall Quality in their assigned areas through the execution of site policies and procedures, programs and work instructions. Ensures all processes and products meet specifications and that products are produced in accordance with GMP requirements. This position is responsible for participating in material receipt, then coordinating sampling and inspection for components, in a sterile manufacturing facility. This position is responsible for ensuring the overall Quality of materials as assigned by Quality Management in coordination with other stakeholders such as Materials Management and Operations, etc.

  • Responsible for execution of procedural documentation as they pertain to various aspects of the receiving and sampling processes.
  • Performs sampling of components.
  • Conduct verifications and checks through accurate material inspections.
  • Identify out of specification materials ensuring segregation and escalation, and perform any activities required within the Trackwise Events system.
  • Management of BPCS for verification and disposition of materials.
  • Maintain retain samples for all primary and secondary components and labeling.
  • Performance of DAF (Destruction Approval) process for rejected materials.
  • Use of Trackwise and Veeva for change controls, as needed.
  • Ensure errors and omissions are resolved according to Standard Operating Procedure (SOP) requirements.
  • Ensure all work is performed and documented in accordance with existing Company policies and procedures, as well as cGMP, health and safety requirements.
  • Ensure all components and raw materials are appropriately prepared for the applicable status disposition, including all relevant documentation.
  • Support generation of logbooks and sheets/labels as required.
  • Perform room, area and equipment clearances that may be necessary for this job function.
  • Assist other Quality Assurance Operations Associates, as needed.
  • Perform any other tasks/duties as assigned by management.
  • High School Diploma or GED equivalent required.
  • Associates or Bachelor’s Degree preferred.
  • At least two (2) years of related experience (QA, Compliance, Auditing, Laboratory or Inspection, within a GMP environment) preferred.
  • Must be able to do work independently.
  • Experience in QA working in a cGMP manufacturing environment (preferred).
  • Working knowledge and understanding of quality assurance principles and familiarity with QA programs.
  • Strong analytical skills, attention to detail and adherence to procedures.
  • Intermediate skills in Microsoft Word and Excel are required.
  • Excellent organizational, interpersonal and communication skills (written and oral) required.
  • Ability to take feedback constructively and function in a team-oriented work environment.
  • Ability to work overtime as needed.
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