What are the responsibilities and job description for the GMP Documentation Specialist - DS 0219VG#01 position at NavitsPartners?
Job Title: GMP Documentation Specialist
Location: West Point, PA
Duration: 12 Months
Description:
The Release and Critical Documentation Specialist is responsible for generating and reviewing documentation for the submission, testing, and release of raw materials, culture media/buffers, and excipients. Primary responsibilities include developing release protocols and preparing/maintaining critical GMP documentation.
Responsibilities:
- Coordinate and maintain the SOP review and approval process.
- Administer various functions within the Learning Management System (LMS).
- Collaborate with Subject Matter Experts to develop training requirements for Standard Operating Procedures, Analytical Procedures, and other training materials.
- Utilize templates for SOPs and supporting SOP documents.
Required Experience & Skills:
- Bachelor of Science or equivalent degree in a related field.
- Working knowledge of cGMP requirements.
- Ability to manage multiple tasks and priorities effectively.
- Strong verbal and written communication skills.
- Understanding of regulations and guidelines governing clinical supply manufacturing and release (CFR, ICH).
- Excellent communication, interpersonal, and organizational skills, including time management.
- Ability to work independently on multiple projects while maintaining critical timelines.
