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QA Specialist II – Katalyst Healthcares & Life Sciences

Katalyst Healthcares & Life Sciences

Title of the Job: QA Specialist II

Location: Austin, TX

Job Description: Responsibilities:Assures the quality of manufactured products and processes per standard operating processes (SOP’S) and GMP (Good Manufacturing Practices).HEAVY Documentation role doing batch review, quality doc approvals Documentation exp. on Resume review of quality documents batch release experience or lab notebook (design, manufacturing or release).Experience in nonconformances 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. Master’s degrees will not supplant any years of experience so must still come with minimum 3 years of experience.Requirements:BS degree or 3-7 years equivalent experience.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.Master’s degrees will not supplant any years of experience so must still come with minimum 3 years of experience.Ability to follow procedures.Strong attention to detail.Strong understanding of med device quality docs.

Company Name: Katalyst Healthcares & Life Sciences

Salary:

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