Who we are…
We are a team of scientists, engineers, technicians, and innovators dedicated to changing the world by developing medical isotopes to treat and eradicate cancer.
We believe in building an environment where collaboration, curiosity, and camaraderie thrive.
We also enjoy darts, cornhole, ping-pong, chili cook-offs, and other fun events that make our company a community where we make a life, not just a living.
Who you are…
You are meticulous, tech-savvy, and passionate about structure and consistency. You thrive in environments where precision matters and enjoy configuring systems to streamline workflows. You’re a natural problem-solver who understands the importance of compliance and documentation in regulated industries. You take pride in being the go-to expert for document control and enjoy collaborating across departments to ensure quality and efficiency.
What you can expect to work on…
- 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.
What you need to succeed…
- Bachelor’s 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.
Great to have…
- 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.
Other things to note…
- Full-time position.
- Company’s 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.
Please provide a cover letter specifically describing the nature of your technical expertise.
