Job Description
Document Control Assistant
Posting Date 2 hours ago (7/12/2018 3:35 PM)
Requisition ID 2018-4895 Job Location(s) Pittsburgh PA United States Position Type Full Time Company Cook Myosite Inc. Category Quality
Overview
Cook MyoSite Incorporated, a division of Cook Incorporated, is a growing, forward-thinking biotechnology organization seeking a full time Document Control Assistant. The Document Control Assistant at Cook Myosite maintains the document management system and ensures quality and compliance for document control procedures and regulations in a cGMP environment.
Responsibilities
Supports all activities related to Document Control in GMP Manufacturing
Maintains the document control and change management system
Serves as document control subject matter expert and has strong knowledge of the EDMS, MasterControl, software
Oversees the daily operations of the Document Control process through MasterControl software. This includes but is not limited to creating, revising, collaborating, formatting, approving, and setting effective date for documents
Maintain files and control access to all original records and controlled documents
Formats and proofreads quality system documents
Performs document control reviews on quality system records
Performs reconciliation and filing of documents
Distributes latest revision documentation to all appropriate users and ensure that obsolete documentation is removed from distribution
Fulfill print requests for document distribution locations
Performs scanning, filing, retrieval, and distribution of documents
Supporting Management during regulatory agency and customer audits and visits
Perform various computer applications on MS Office programs
Perform clerical typing duties to generate documents as necessary
Maintain regular and punctual attendance
Must maintain company quality and safety standards
Exemplifies Cook MyoSite Core Values
Qualifications
Must have, at a minimum, an undergraduate degree in any life science, business, other related field (BL1) or acceptable related document control experience
Must possess excellent organizational skills and the ability follow complex processes, procedures and systems
Demonstrate critical thinking and ability to execute goals set by the organization and Department Manager
Proficiency in MS Office and other general office equipment
Must maintain a high level of professionalism, business acumen
Must have effective verbal, written and interpersonal skills
Maintain composure and competence under stressful situations; flexibility and adaptability
Ability to work in collaborative and independent work situations and environments with minimal supervision
Basic understanding of cGMP, 21 CFR Part 11, and related regulations associated with Bio/Pharmaceutical product manufacturing
Physical Requirements:
Must be able to sit at desk, in meetings and/or work on a computer for long or extended periods of time.
Physically capable of standing, stooping, kneeling, climbing, reaching, twisting and bending with or without reasonable accommodation
Climbing a mobile ladder and/or other types of ladders on occasion with or without reasonable accommodation
Laboratory and office setting
Ability to work under specific time constraints
Must be capable of performing PPE gowning procedures on an occasional basis to enter BioSafety Level II including safety glasses, lab coat, gloves, specialized clothing including laboratory scrubs (pants and shirt) and appropriate shoes required on occasion
General office, warehouse and laboratory setting with potential (limited) exposure to hazardous chemicals and/or harsh disinfectants while in BioSafety Level II
Must be able to work extended hours beyond normal work schedule to include, but not limited to, evenings, weekends, extended work hours and/or extra work hours, sometimes on short notice as required
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"We are proud to be an equal employment opportunity employer for minorities, women, protected veterans, disabled individuals, and any other protected class."Cook will consider for employment qualified applicants with criminal histories in a manner consistent with applicable federal, state, and local law.