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QA Associate

Indianapolis $65K-$80K Contract

Job Responsibilities:

  • Administer the site's change control process, managing the electronic change control system, and overseeing the change review board.

  • Provide support for various quality system processes, including managing change deviation/CAPA, document control, and validations.

  • Play a crucial role in supporting projects aimed at enhancing change control processes at the facility.

  • Monitor activities and prepare metrics related to your responsibilities with a commitment to escalating issues appropriately.

  • Responsible for collaboration with cross-functional personnel will be encouraged to continuously improve the Quality System.

  • Support the development and execution of training programs for employees on quality assurance practices.

  • Document current state, risks, and process improvement goals

  • Ensure compliance with cGMP, Company SOPs and FDA requirements during all phase of operations

  • Perform process checks and verification's to ensure the quality is maintained

  • Stay informed about industry regulations and best practices to ensure ongoing compliance.

Qualifications:

  • Bachelor's degree in a relevant scientific or engineering field.
  • 2+ years experience in QA pharmaceutical or radiopharmaceutical industry.
  • Strong knowledge of regulatory requirements, including FDA and cGMP.
  • Excellent attention to detail 
  • Effective communication and interpersonal skills.
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