Quality System Document Control Specialist

• Configure and manage document lifecycles routing and approval workflows within the EDMS/EQS.
• Serve as system administrator for EDMS/EQS providing technical support and implementing upgrades.
• Train users on system functionality and document workflows including MasterControl best practices.
• Generate and analyze reports on document status overdue tasks and workflow aging.
• Support internal and external audits by retrieving documents and demonstrating system compliance.
• Apply consistent formatting across all Quality System documents using advanced tools.
• Develop and manage document templates to ensure formatting compliance.
• Archive and manage document history in accordance with retention policies.
• Monitor document control procedures and ensure cross-departmental compliance.
• Act as SME for document control practices and tools.

• Bachelors degree in Business Administration Information Management Technical/Professional Writing or a quality related field (or equivalent experience)
• 3 years in a document control or records management role
• 2 years of experience administering or configuring an EDMS/EQS
• Embraces & models the Niowave Values of Teamwork Courage Integrity and Upright Zeal.
• Understands how to integrate into a new team/organization appreciates the history of current state know how and when to make suggestions as well as using just the right pace to reach the improved future state.
• Understands your own communication and learning styles can assess others styles and is able to find the right path to connect the two.
• Resilient self-starter who learns and acts quickly within a rapidly evolving environment.
• Demonstrates excellent organizational and project management skills for self and teams
• Ability to configure workflows set up user roles/permissions and define metadata structures.
• Advanced proficiency in Microsoft Word (styles table of contents section breaks formatting tools).
• Familiarity with PDF editing and publishing tools (Adobe Acrobat Pro)
• Understands regulations (e.g. 21 CFR Part 11 ICH Q10 ISO 13485) for documentation electronic records and systems.
• Proficient application of GDP principles in all controlled documents.
• Understands documentation structure revision control and change control.

• 5 years in a document control or records management role
• 3 years of experience administering or configuring an EDMS/EQS
• Experience applying complex document formatting and template creation
• Experience working in regulated industries.
• Certification in Document Control or Records Management.
• Experience with automated document workflows and metadata management.
• Experience with writing Standard Operating Procedures using industry standards such as Information Mapping or other digital literacy tools.
• Experience with archival best practices and setting up/maintaining retention schedules.
• Experience with computer system validation.

• Full-time position.
• Companys standard operating hours are Monday thru Friday 6a 6p with production related activities requiring 24/7/365 shifts.
• This position will have regular working hours during M F with an expectation of adjusting to work outside of the standard operating hours as needed.
• Niowave has multiple locations within the Lansing area. Travel between locations is expected in the role.

Required Experience:

Unclear Seniority