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QA Associate II - Documentation

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Cincinnati, OH
Job Type
Direct Hire
Jun 11, 2019
Job ID

This function is responsible for supporting the daily manufacturing and facility operations.  Functions include handling the Site Documentation Room activities such as: storing, and retaining electronic and hard copy GMP documents. Additional functions; discrepancy tracking, document review, training program support, shutdown notifications, work orders, TrackWise reporting, shift communication and CAPA tracking. This function thresholds events to Senior Associate when they are outside of the area of responsibility.

The position will perform general QA work, using their ability as a skilled contributor in completing tasks where judgement is required in resolving problems and making recommendations.  Works on problems of a diverse scope where analysis and problem solving is required.  Receives general oversight and guidance on approaches to complete project related tasks.  Applies job related skills and understanding of policies and standards in completing tasks.


  • Requires a Bachelor’s degree in a scientific discipline or equivalent.



  • Minimum of 2 years’ experience in a Quality Assurance role in the pharmaceutical industry.

  • Skills / Abilities:

  • Working knowledge of US Drug Product GMP requirements and associated guidelines.

  • Experience in Pharmaceutical Quality Assurance, including the ability to identify and resolve compliance issues.  

  • Ability to increase others knowledge of US end European GMP regulations and guidance.

  • Strong written and oral communication skills.

  • Experience in administration of quality systems for drug product manufacturing and quality control operations, especially in Documentation Controls.

  • Strong written and oral communication skills.