QA Assistant

About the job

Candidate will work with Quality Assurance as a Quality Assistant to ensure compliance of manufacturing processes in a GMP environment. This person will serve as reviewer and/or approver for required documentation in a plant setting. This position is very project orientated, so the QA Assistant can expect every day to be different with changing responsibilities and priorities. 

QA Assistant

  • Review Certificate of Analysis for incoming goods and verify associated documentation
  • Visually inspect all incoming goods to ensure that the packaging is not damaged, and that quality of the product is not compromised by the condition of the package
  • Physically inspect packaging components to ensure all items meet quality standards
  • Sample incoming goods (packing components and Active Pharmaceutical Ingredient)
  • Send samples of API to third party lab for testing
  • Track status of API samples sent to third party lab for test results
  • Review lab test results to ensure that sampled products meet quality standards
  • Release products and API that meet quality standards
  • Use AX to complete checklists and input data as needed
  • Revise and create SOPs for incoming quality processes
  • Initiate investigations for Incoming Quality
  • Communicate and collaborate with Supply Chain, Production, Quality, and Quality Control on all Incoming Quality processes and the release status of raw materials tested for quality
  • Data entry for raw material test results, incoming material inspection reject rates, and supplier qualification and management.
  • New item setup in AX.
  • Conduct facility and/or supplier assessments, raw material release, and line clearances
  • Author and update SOPs as needed
  • Follow GMP guidelines and adhere to SOPs and GMP requirements
  • Communicate QA issues to employees and managers in a tactful manner
  • Work on multiple projects at once with changing deadlines and priorities

Set yourself apart


  • BS in science or 2-6 years of applicable experience
  • Experience working in a laboratory or process manufacturing setting
  • Experience working in a regulated environment (GMP)
  • Detail oriented, ability to get along with a variety of different personalities, multitasking skills, and works well under pressure
  • Strong verbal and written communication skills
  • Technical writing and review ability
  • Desire to work in an office setting as this position is not laboratory focused


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