Documentation Control Specialist - I

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.