Demo

QA Specialist

Katalyst Healthcares and Life Sciences
Austin, TX Full Time
POSTED ON 1/19/2025
AVAILABLE BEFORE 4/19/2025

Responsibilities :

  • Heavy Documentation role doing batch review, quality doc approval Documentation exp. on Resume review of quality documents, batch release experience or lab notebook (design, manufacturing or release).
  • Experience in non-conformances and CAPA is a plus.
  • Must have strong attention to detail.
  • Must know and be able to follow procedures, review document requirements and determine if acceptable for procedure and if not escalate. Internship, co-ops and schooling will not be considered.
  • ability to follow procedures.
  • strong attention to detail.
  • strong understanding of med device quality docs.

Requirements :

  • Master's degrees will not supplant any years of experience so they must still come with a minimum of 3 years of experience.
  • This position will support 3rd parties for medical devices, device history records and mostly will handle Batch Records.
  • Must have bachelor's degree preferably in STEM Engineering / Science degrees are best fits.
  • Must have a minimum of 3 years of experience in a medical device or pharma regulated environment, preferably in manufacturing.
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