Job Description

Job Name: Documentation Specialist II 
Location: West Point, PA
Hours/Schedule : Mon- Fri 8am- 5pm
Type: Contract

Job Overview
The Release and Critical Documentation Specialist will be responsible for the generation and review of documentation for the submission, testing, and release of raw materials, culture media/buffers, and excipients.

Responsibilities :

• Release protocol development, preparing/maintaining appropriate critical GMP documentation.
• Coordinate and maintain SOP review and approval process
• Administering various functions within the Learning Management System (LMS)
• Working with Subject Matter Experts, develop training requirements for Standard Operating Procedures, Analytical Procedures and other training material
• Utilize templates for SOPs and supporting SOP documents

Requirements:

• Bachelor of Science or equivalent degree in a related field.
• 4+ yr. Experience
• Strong Technical Writing Skills
• Good manufacturing practices experience
• Ability to manage projects/work to schedule/deadlines
• Understanding of applicable regulations and guidelines governing clinical supply manufacture and release (CFR, ICH) 

Benefits
System One offers eligible employees health and welfare benefits coverage options, including medical, dental, vision, spending accounts, life insurance, voluntary plans, and participation in a 401(k) plan.

Ref: #558-Scientific

Job Tags

Contract work,

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