Raw Material Release Specialist

Nebraska  ‐ Onsite
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Keywords

Description

RESPONSIBILITIES:
Determine appropriate testing requirements for Raw Materials (new and re-evaluation).
Upon completion of all testing and documentation requirements approve Raw Materials using appropriate system. Assign appropriate re-evaluation and expiration dates.
Work with colleagues to ensure Raw Materials are approved prior to their need dates.
Provide input to assist Quality Operations in updating/creating their Specifications.

SKILLS:

MINIMUM REQUIREMENTS:
Bachelor's Degree (B.A. or B.S.) in biological science or other related disciplines.
Minimum 3 years of experience in vaccine or pharmaceutical manufacturing, quality operations or regulatory compliance.
Demonstrated ability to plan, organize, coordinate and complete work with very high attention to detail and within specified timelines.
Basic understanding of pharmaceutical or vaccine manufacturing, testing and distribution.
Basic knowledge and understanding of applicable USDA, FDA & EU regulations and guidance, as well as corporate quality standards.
Excellent written and verbal communication skills.

PREFERRED REQUIREMENTS:
5+ years of progressive experience in quality operations, pharmaceutical or vaccine manufacturing or regulatory compliance with at least 3 years at a Lead level.
Experience with Quality Assurance auditing, with Quality Auditor or similar certification.
Start date
n.a
From
Synectics
Published at
30.08.2014
Project ID:
767583
Contract type
Freelance
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