SQAFYI - Software QA Resource - FYI

US: Life Sciences Quality Assurance Engineer

To see other opportunities, please visit http://sqa.fyicenter.com
Date: 25-Aug-2015

Life Sciences Quality Assurance Engineer

Develops and implements processes, procedures, forms, metrics and tools for quality systems.

Reviews and revises/approves quality and validation documents.

Experience in change control, non-conformance investigations, new material and batch release, quality systems auditing and validation review.

Conducts training for Life Sciences, Bioprocess and IVD teams in quality systems processes to ensure adherence

•Minimum 3 years, prefer 5 years in quality, validation or compliance role in an IVD industry •Requires intermediate skills in MS Office, SPC software, knowledge of ISO standards, and document control software •QA and QMS experience •Experience in development of GMP systems •Experience with FDA/regulatory audits desired. EMEA experience preferred. •Understanding of FDA 21 CFR, ISO9001 requirements and how it applies to crucial raw material vendors •Works on assignments requiring considerable judgment and initiative; understands implications of work and makes recommendations for solutions •Excellent verbal and communication skills •Project management experience/ organizational skills •Ability to work across departments, silos and global cultures

To apply for this position, please visit this Website.

Thank you,
Team SQAFYI - Software QA Resource FYI

US: Life Sciences Quality Assurance Engineer