Pace Analytical

Quality Engineer Assistant

US-MN-St. Paul
ID
2017-1942
# of Openings
1
Category
Science

Overview

Candidate will work with Quality Assurance as a Quality Engineer 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 pilot plant setting. This position is very project orientated, so the QE Assistant can expect every day to be different with changing responsibilities and priorities.

Responsibilities

  • Review lab data, validation and stability protocols/documents, batch tickets, specifications, and manufacturing orders for compliance
  • Support manufacturing through timely process of deviations, change controls, CAPA complaint handling, and investigations to ensure quality products
  • 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

Qualifications

  • BS in Chemistry or related science with 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 or engineering focused

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