What are the responsibilities and job description for the Documentation Specialist II position at System One?
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:
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.
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
- 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)
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.
