Specialist QA

Specialist QA with:

• Experience in computer systems validation or computer systems quality assurance (consulting background technical proficiency).
• Robust knowledge of and experience with processes involved in manufacturing and distribution, QA, QC, and Process Development.
• Experience with Validation of GxP applications, Validation Master Plan, Installation Qualification (IQ), Risk Assessment/GxP assessment, Operational Qualification (OQ), and Performance Qualification (PQ) Protocols, Test Scripts, and Completion/Summary Reports approvals as per the compliance requirements.
• Validated experience as Quality Contact for complex projects involving drug substance/products with experience in commissioning and qualifications.
• Available to work twelve (12) hours shift.

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Requirements*

• Master’s degree Life Science and/or Engineering and* 3 years* of Quality or Manufacturing support experience in pharmaceutical, GMP regulated environment or Bachelor’s degree & 5 years of quality or manufacturing support experience in pharmaceutical, GMP regulated environment
• Available to work twelve (12) hours shift.
• Bilingual (Spanish/English) (both written and oral)
• Microsoft Office spreadsheet and application skills and presentation knowledge.

Master’s degree Life Science and/or Engineering and 3 years of Quality or Manufacturing support experience in pharmaceutical, GMP regulated environment or Bachelor’s degree & 5 years of quality or manufacturing support experience in pharmaceutical, GMP regulated environment Educational background in Bilingual (Spanish/English) (both written and oral) Microsoft Office spreadsheet and application skills and presentation knowledge.

Job Type: Full-time