Documentation Specialist

Title: Documentation Specialist - IILocation: West Point, PADuratiion:12 Months Writing specification protocols and Managing SOP's. Raw material release material for SOP .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 mediabuffers, and excipients. Primary responsibilities include release protocol development, preparingmaintaining appropriate critical GMP documentation.Responsibilities also include:Coordinate and maintain SOP review and approval processAdministering 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 materialUtilize templates for SOPs and supporting SOP documentsRequired experience and skills:Bachelor of Science or equivalent degree in a related field.4+ yr. Experience Strong Technical Writing Skills Good manufacturing practices experienceAbility to manage projectswork to scheduledeadlinesCoherent Communication skills (no proof reading).Good project management skills Working knowledge of cGMP requirementsDemonstrated ability to manage multiple tasks and prioritiesEffective verbal and written communication skillsUnderstanding 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.

Created: 2025-02-24