Find Document control and training specialist Job in West chester, Ohio | Snaprecruit

Full-time

West chester Ohio United States

No

• Establish and maintain effective document control processes to ensure the accurate and controlled distribution of quality and regulated documentation, including policies, procedures, work instructions, specifications, and templates.
• Responsible for the execution of all change management requests and follow through to project completion.
• Review and evaluate quality documentation for accuracy, consistency, and compliance with
• established standards and regulations.
• Collaborate with subject matter experts to make necessary revisions and improvements to documents.
• Establish and maintain a centralized system for storage, retrieval, and archiving of quality documents.
• Manage the approved training program.
• Oversee the training management system to ensure training is provided in a timely manner through the employee onboarding and/or document revision processes.
• Ensure document version control and maintain an audit trail of changes.
• Facilitate training programs and workshops to promote awareness and understanding of change management requirements among employees. 
• Communicate updates and changes in documentation to relevant stakeholders.
• Conduct regular audits and inspections, in partnership with the quality manager and quality assurance team, to ensure compliance with internal quality standards and relevant regulatory requirements. Address non-compliance issues and recommend corrective actions.
• Identify opportunities for process improvement and participate in the development and implementation

• Previous experience in a similar role of a document administration, preferably in a regulated industry such as pharmaceuticals, medical records, medical devices, or manufacturing.
• Competency in complex reading, writing, and proofreading technical documentation.
• Strong understanding of quality management systems, document control principles, and
• regulatory compliance (e.g., ISO standards, FDA regulations)
• Must have strong attention to detail, excellent organizational and communication skills, ability to problem solve, and knowledge of use and operation of standard office equipment, such as email, internet, word processing, databases, and spreadsheets.
• Experience working with FDA, 21 CFR part 11 preferred.

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