Documentation Specialist

Qualifications:

Required experience and skills:

• 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
• Coherent Communication skills (no proof reading).
• Good project management skills
• 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.

Responsibilities:

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.

• 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