Specialist Qa F0043

Company Overview

Our company specializes in providing Integrated Engineering, Maintenance, Utilities and Specialized Technical Services for the Pharmaceutical, Parenteral, Chemical, & Medical Devices Manufacturing business sectors in compliance with Federal Government Regulations.

Qualifications and Skills

Bachelor's degree in Sciences/Engineering and 5 years of Manufacturing experience in a GMP regulated industry
Biotechnology industry experience
Understanding of bio-processing unit operations
Technical writing
Control charting
Root Cause Analysis

Responsibilities and Duties

Approve process validation protocols and reports for manufacturing processes.
Request Quality on incident triage team.
Approve Environmental Characterization reports.
Represent QA on NPI team.
Lead investigations and site audits.
Own site quality program procedures
Support facilities and environmental programs.
Review and approve Work Orders.

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