Document Control Clerk - 1st Shift

EPTAM Precision Metals is looking for a Document Control Clerk - 1st Shift to join our team in Colorado Springs, CO. Join us as we manufacture medical implants and internal fixation devices that bring positive outcomes for our customers and life impacting experiences for their patients.

EPTAM Precision Metals, nestled in Colorado Springs Colorado , operates from a high-tech, 70,000-square-foot facility, specializing in medical implants and instrumentation. Our facility, accredited with FDA-registration and ISO 13485 certification, features essential resources including a Class 7 clean room, automated inspection, a validated supply chain, and a dedicated R&D cell.

At EPTAM , precision is paramount. We provide 3-, 4-, and 5-axis CNC milling, gun drilling, water jet cutting, Swiss and Super-Swiss machining, and EDM machining. With our extraordinary team and processes, we deliver unparalleled services to our employees, customers, and the end-users of our medical devices.

EPTAM Solutions , our parent company with locations nationwide, is at the Heart of Manufacturing. We recognize our parts touch lives, and our teams assume this responsibility with vigor. Our minds never sleep.

POSITION SUMMARY: The Document Control Clerk manages and oversees documents for at the site level of the organization, ensuring that documents are changed, controlled, issued, stored properly, and are accessible. To execute their duties, the Document Control Clerk, coordinates change control activities with all departments to implement and maintain the document management and control process.

Document Control I, ensures documents are approved and signed by the appropriate parties and ensures that all of the data is stored and backed up as required by P0001 Control of Quality Records.

Has overall responsibility for the Change Control Process which includes but not limited to;

• Review document changes for adherence to Document Control procedures
• Distributing updated documents to production areas as well as suppliers
• Fulfilling Document Retrieval Requests
• Have a thorough understanding of the filing system to be able to quickly and effectively retrieve documents and data as required.
• Organizing and Archiving documents involving scanning, copying, physically and /or electronically filing
• Represent the document control department as required during, customer, internal and ISO audits as well as FDA inspections
Knowledge of Good Documentation Practices (GDP) and Good Manufacturing Practices (GMP), ISO 13485 and FDA 21 CFR Part 820 Sub parts A, D and M

• Education: High school diploma or general education degree (GED
• Experience: 1 year of related administrative experience and/or training, or an equivalent combination of education and experience.
Preferred Qualifications: Must possess strong computer skills and be proficient in Microsoft Office and Outlook.

ADP1147

2XB-240410-134