What are the responsibilities and job description for the Documentation Specialist - II position at Integrated Resources, Inc?
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
Quals--
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.
