Senior Document Control Specialist

Start Time (AM / PM)8 : 00am End Time (AM / PM) 5 : 00PM Exempt / Non Exempt : Non Exempt Years Experience : 5+ years of experience Skills : Have a strong background with quality systems Have experience with documentation releases through a document management system Work cross-functionally and in a matrixed environment Experience with Windchill document management systems Education : BA Degree Required Duties : Under minimal supervision performs file maintenance and / or updates operating procedures, work instructions, quality system templates and documents. Manage document change orders, reports and all other regulated / controlled documentation while operating and maintaining the reproduction and documentation system. Also, aid in the release of all controlled documentation by (but not limited to) providing information, solving problems, catching issues, and entering information into various computerized systems. Serve internal customers to meet the business needs. Will verify for accurate completion of change requests, and other Quality System Documentation in Windchill and legacy document control system. Will function as Windchill Administrator by supplying training and support to users as well as assist in Validation of System through upgrades and workflow changes. Will maintain and review consistency checks for document formats and contents. Will coordinate with the Change Review Team to prioritize change requests based on business needs. Will manage with Change Management Process with the Change Management Team when changes are needed. Will train users on various systems and processes as needed. Will assist in retrieving documentation during internal and external audits. Will assist in training new employees. Will assist with special projects as assigned by Manager. Will take on the responsibility in prioritizing of Document Control workload to meet business needs. RESPONSIBILITIES :

• Perform the role of Change Order Coordinator for the facility.
• Independently facilitate the Document Change Order and Deviations including formatting, coordinating the review and approval process, tracking and routing controlled documents, and release of documents in a timely manner.
• Ensure that any new documents or changes to existing documents are appropriate, justified, accurate, complete, meets Good Documentation Practices, and approved by the required functional areas according to established procedures.
• Issue document numbers, lab notebooks numbers and part numbers.
• Assist in drafting, formatting, editing and rewriting SOPs in support of the quality systems across the organization.
• Ensure document reviews are performed periodically in a timely manner by Document Owners. Manage archiving, obsolescence and document storage.
• Perform Document Control training for new and existing employees.
• Support development of QA-related training materials.
• Assist with training assignment and collection of training metrics in Metro.
• Respond to queries and issues raised by Document Owners and Approvers in a timely manner.
• Assist with internal and external audits.
• Support the continuous improvement to the Quality Management System, with a specialty focus on document control and change order processes. BASIC QUALIFICATIONS | EDUCATION :
• Bachelor's Degree and / or an equivalent combination of education and experience.
• 2 years or more of experience in Quality Assurance or in Document Control, in a laboratory, medical device or similarly regulated industry.
• Working Knowledge of 21CFR820, ISO 13485 : 2016 standard.
• Experience processing changes using an electronic documentation system
• Experience with technical writing, formatting and trending of data.
• Electronic Document Management System experience required.
• Agile experience preferred. COMPETENCIES :
• Proficient with Microsoft Office, including Word, Excel, PowerPoint, electronic document control tools and Visio
• Ability to understand QMS procedures and ability to recognize deviations from approved documented procedures
• Self-starting, detail oriented, and ability to focus on task at hand
• Ability to work independently with multiple departments to resolve Document Control issues
• Must be able to work effectively in a fast paced, team-oriented environment
• Well-developed English written and verbal communication skills