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Document Control Specialist

Company: Vit-Best Nutrition
Location: Tustin
Posted on: February 23, 2021

Job Description:

POSITION SUMMARYThe primary purpose of the Document Control Specialist is to ensure the Document Control System across all platforms is fully operational and ensures the integrity of document creation, version control, storage, retrieval, and lifecycle management are effectively implemented.Ensure Document Management is consistent across the organization while maintaining control and traceability of the documentation history in compliance with 21 CFR part 111. DUTIES & RESPONSIBILITIES (Duties may include, but are not limited to, the following):- Responsible for managing the creation, revision, and retiring of all controlled documents; including but not limited to specifications, routers, SOP's, work instructions, forms, templates, and policies.- Support the commercialization of new products in executing the creation of routers in the Quality Management and ERP system.- Responsible for managing the the Change Control Board and Impact Assessment surrounding facility, equipment, software, processes, customer specifications, controlled documents and procedural changes.- Maintain the Document Management Systems in QAD and QMS.- Ensure document numbering, formats, issuance, review, revisions, dispatch, recording and archiving follow 21 CFR 111 regulations.- Responsible for the integrity of the data entered into the ERP and Quality Management System.- Responsible for identifying process improvement opportunities throughout the change control process.- Maintain and manage electronic and hard copy documents as required.- Collaborate with Product Development, Acct. MGMT, R&D and OPS to ensure control and timing of documentation and data in alignment with business needs.- Assist in the preparation of validation of changes throughout the company and issue of reports as required.- Develop, standardize and monitor technical documents review, approval and implementation in accordance with agreed schedule with other departments.- Produce project management status reports as needed.- Assist with various 3rd party, Regulatory and customer Audits and inspections.- General document control activities such as photocopying, scanning, and filing as needed.- Other responsibilities and tasks assigned by managementQUALIFICATIONS & REQUIREMENTS- Experience in Network-based system, Quality Management Systems Software (QMS) & QAD.- Excellent verbal and written communication skills.- Experience in creation, review, and approval of manufacturing specifications.- Knowledge of 21 CFR regulations.EDUCATION & EXPERIENCE- Bachelor's Degree in Biology, Food Science, or related field preferred.- Minimum 5 years related experience and/or training; or equivalent combination of education and experience.

Keywords: Vit-Best Nutrition, Tustin , Document Control Specialist, Other , Tustin, California

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