Sr Specialist QA

Biopharma Consulting Services, Inc. • Juncos, PR, US • published 2026-09-21 20:11:33.926589

Description

In support of Quality Assurance program acts as the technical specialist. Review and approve product MPs. FUNCTIONS \- Approve process validation protocols and reports for mfg. processes. \- Represent Quality on incident triage team. \- Approve Environmental Characterization reports. \- Release of sanitary utility systems. \- Approve planned incidents. \- Represent QA on NPI team. \- Lead investigations. \- Own site quality program procedures. \- Designee for QA manager on local CCRB. EDUCATION/LICENSES \- Doctorate degree and 2 years of directly related experience or Master's degree and 6 years of directly related experience or Bachelor's degree and 8 years of directly related experience or Associate's degree and 10 years of directly related experience or High school diploma / GED and 12 years of directly related experience. Requirements: The candidate should have experience in Commissioning and Qualification, Equipment validation, QRAES, Kneat, Good Documentation Practices, Change Controls, SOP’s etc Job Type: Full\-time Pay: From $50\.00 per hour Education: * Bachelor's (Preferred) Experience: * Specialist QA: 8 years (Preferred) * inspection and packaging processes validation: ...

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