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Job Field: Legal Jobs
Location: Mojave, CA
Salary: $Not stated

JOB SUMMARY:

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<tr><td valign="top" width="450"><b>Key Responsibilities
Supports/conducts IQ, OQ, PQ validation studies of
equipment and processes, including some software
related validations i.e. spreadsheets
participates on technical project teams as subject
matter expert on validation regulations
develops/reviews and approves validation protocols
and final reports.
Designs process characterization studies DOE,
conducts statistical analysis of results to
identify critical parameters and improves process
capability.
Supports technical troubleshooting/failure
investigations involving manufacturing non-
conformances and product failures by leading or
participating in FMEA, Hazard Analysis, and Fish
Bone technical reviews.
Participates on Design Control New Product
development teams advises the team on design
control requirements develops, reviews and
approves design control deliverables.
Optimizes the Quality System Validation and Design
Control programs.
Ensures conformance to in-house specifications and
GMP.
Minimum Requirements/Qualifications
5  8 years of work experience in Quality Systems
within a regulated/medical device environment
Bachelors Degree in chemical engineering, process
engineering, or material sciences
Thorough understanding of cGMP and ISO
requirements, specifically validation and design
control regulations...For more information please
see URL

KEY REQUIREMENTS:

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None Bachelors degree