Documentation Control Associate

About Nuclein:

Nuclein is an Austin-based, private equity funded, medical device company that offers an innovative, FDA EUA authorized, rapid PCR, point-of-care system. The Nuclein® DASH™ Rapid PCR System is easy-to-use, affordable, and provides PCR results in only 15 minutes.

Our vision is to enable simple, affordable, rapid and accurate testing for everyone. We are a dedicated, talented and diverse team of scientists, engineers and experienced professionals who are driven to excel and make a significant contribution to the world. At Nuclein, we offer a fast-paced, exciting, collaborative environment where individual contributions are highly valued as we work to expand the use of our transformative testing technology in the market.

Please visit Nuclein.com for more information about our company's history, technology, and vision.

Position Summary:

The Documentation Control Associate will provide direct support for the electronic and physical incorporation, release and control of documents and Quality Records associated with Nuclein’s operations, development and research functions. The Documentation Control Associate will also provide document support for Nuclein calibration and maintenance programs.

Responsibilities:

• Execute document control responsibilities and facilitate the change control process from initiation through implementation in the Nuclein electronic Quality Management System (eQMS), including review of change requests to ensure compliance to procedures
• Assign training to Nuclein employees on new/revised documents in the eQMS according to procedures
• Incorporate document information (e.g. dates, revisions, redlines, etc.) in accordance with approved change requests
• Provide support and training for end users on the document control process and system
• Maintain physical and electronic quality records, including organizing, filing, back-up, retrieval, and preparing records for off-site archival
• Maintain equipment files and associated records (e.g. calibration reports, maintenance forms, etc.) and update equipment service logs
• Maintain software validation documentation for the eQMS, including execution of protocols and generation of reports
• Assist in the preparation of metrics and reports related to document control and training
• Support internal/external audits and 3rd Party inspections
• Perform other duties and responsibilities as assigned

 Qualifications:

• High school diploma required
• At least 2 years of document control experience in ISO13485 / 21 CFR 820 environments
• Strong computer and system skills (e.g. Word, PowerPoint, Excel, Databases)
• Experience in working with electronic Quality Management Systems (eQMS) required
• Excellent interpersonal skills both written and oral communication
• Detailed oriented with strong organizational skills