Document Control Clerk

Description

Biomerics is a world-class manufacturer and innovative polymer solutions provider for the medical device and biotech industries. As a vertically integrated company, we specialize in designing, developing, and producing medical devices for diagnostic and interventional procedures. We are focused on next-generation solutions for vascular access, electrophysiology, cardiac rhythm management, neurovascular, structural heart, and cardiovascular markets.

At Biomerics, we are dedicated to our diverse employee base. We understand that a strong, skilled, and engaged workforce is the foundation of our continued success as a business. We strive to live up to the Biomerics values in all our interactions. It is an exciting time to be part of our collective team, and there is no limit to the impact that can be achieved here  improve and advance the lives of our employees and patients who depend on our products.

At Biomerics, we believe in integrity, partnership, empowerment and accountability, trust, agility, teamwork, and excellence, and we care. Our team-oriented, customer-focused corporate culture prioritizes building strategic, mutually beneficial partnerships with customers and our team members.

A Document Control Clerk I is an entry-level position responsible for managing, organizing, and maintaining the accuracy of critical documentation throughout its lifecycle. This role ensures all documentation—such as Standard Operating Procedures (SOPs), Work Instructions (WIs), and Document Change Requests (DCRs) complies with regulatory standards like ISO 13485 and FDA 21 CFR Part 820. The clerk plays a vital role in ensuring that only the most current, approved versions of documents are used in production.

• Handle the intake, scanning, indexing, formatting, review, and archiving of technical documents, drawings, and records.
• Maintain documentation accuracy by managing revisions, tracking approval workflows, and removing obsolete documents from workstations.
• Assist the Quality Assurance (QA) department with preparing documentation packages for audits and inspections.
• Accurately enter metadata, update databases, review applicable documentation, and maintain relevant Quality System Logs for NCMR (Non-Conforming Material Reports), CAPA (Corrective and Preventive Actions), and CC (Customer Complaints).
• Administer training records and ensure employees are trained on new or revised SOPs.
• Review of relevant manufacturing and/or quality records to ensure compliance with cGMP (current Good Manufacturing Practices), and GDP (Good Documentation Practices).
• Develop, draft, revise, and edit technical documentation, including manuals, procedures, and requirements documentation.
• Use rough outlines, resource materials, and information obtained through research or provided in meetings by technical specialists to develop documentation.
• Communicate with internal and external customers to ensure documentation is processed, reviewed, and supplied according to the needs of the internal and external customers.
• Familiarity with product/processes to identify any potential errors within documentation.
• Ability to track and trend relevant QMS Data as required (Customer Complaints, CAPAs, NCMRs).

• High School Diploma or GED required; an Associate’s degree in a related field is often preferred.

• 0–2+ years of experience in document control, preferably in a regulated manufacturing (medical device, pharma, or aerospace) environment.
• Strong proficiency in Microsoft Office Suite (Word, Excel, Outlook, PowerPoint) and experience with Electronic Document Management Systems (eQMS) such as Net Suite or Grand Avenue.
• Meticulous accuracy in reviewing documents for errors and ensuring compliance with formatting standards.
• Good communication and critical thinking skills
• Familiarity with FDA 21 CFR Part 820, ISO 13485, and Good Documentation Practices (GDP).