Documentation SpecialistThe 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 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 fieldWorking 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.Kindly share your resume with answers; Q1: How many years of exp in generation and review of documentation for the submission, testing, and release of raw materials, culture media/buffers, and excipients. Q2: How many years of exp in release protocol development, preparing/maintaining appropriate critical GMP documentation.
Q3: Which year you completed your Bachelors and in which Discipline Q4: how many years of exp / knowledge of cGMP requirements Q5: How far you live and how will you commute daily to 770 Sumneytown Pike, West Point, PA Q6: How soon you are ready to start and what is your per hour rate