New 
Documentation Specialist
 Spectraforce Technologies | |
 United States, Pennsylvania, West Point | |
 Feb 25, 2025 | |
|
Documentation Specialist
Location: West Point, PA 19486 (On-site initially; potential hybrid model after training - 3 days on-site, 2 days remote) Duration: 1-year contract (potential for extension based on business needs and performance) 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. 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 | |