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QA Associate III (Investigations)

Title: Quality Associate III

Duration: 8 Months with possible extensions

Location: Onsite Lexington, MA

Investigator responsibilities will be to support deviations, investigations, and related reports to closure within the established timelines for the Quality Control department.

Will conduct investigations to determine potential product impact, identify root cause and implementation of corrective and preventative actions in accordance with established procedures and timelines.

Focus areas include environmental monitoring of clean rooms and utilities for a biologics manufacturing plant, as well as analytical methods.

Responsibilities:

  • Influence the organizational control of Quality Systems: Create/monitor/author deviations, Out of Specification (OOS) and Out of Tolerance (OOT) and environmental alert actions.
  • Monitor GMP investigations progress and support process to closure. Escalate conflicts that arise.
  • Work cross-functionally to assess and analyze deviations and investigations to determine impact and root cause.
  • Identify, initiate and track corrective and preventative actions for investigations, OOS and OOT
  • Track and identify Quality System and root cause trends and identify opportunities for operational improvements

Education & Experience Requirements:

  • Bachelor's degree in Science or a related discipline with 5 years of industry experience in a pharmaceutical/biotech.
  • Minimum of 3 years related experience in a Quality Control or Manufacturing setting. Microbiology background helpful.
  • Previous technical writing experience preferred
  • Strong written and verbal communication skills.
  • Must be proficient with Microsoft Office applications, including Word, Excel and Power Point.
  • Experience with more advanced document management applications a plus (including but not limited to TrackWise and SAP).
  • Ability to manage multiple priorities simultaneously.
  • Lead problem resolution meetings/teams effectively.
  • Ability to shift priorities to meet required deadlines.
  • Effectively communicate issues cross-functionally in a timely manner.
  • Understanding of industry regulations and cGMP compliance.
  • Ability to apply industry regulations to decision-making process.

Sthree US is acting as an Employment Business in relation to this vacancy.