Documentation Control Specialist - I
AA2IT
Documentation Specialist
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. Primary responsibilities include release protocol development, preparing/maintaining appropriate critical GMP documentation.
Responsibilities also include:
- 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
Required experience and skills:
- Bachelor of Science or equivalent degree in a related field
- Working knowledge of cGMP requirements
- Demonstrated ability to manage multiple tasks and priorities
- Effective verbal and written communication skills
- Understanding of applicable regulations and guidelines governing clinical supply manufacture and release (CFR, ICH)
- Must have strong communication, interpersonal, and organizational skills, including time management.
- Candidate must have the ability to work independently on several projects maintaining critical timelines.
Vacancy posted 3 days ago
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