Quality Tech I / Document Control Clerk I in Fairfield, California at Biomerics

The Document Control / Quality Technician I is a member of the Document Control and Quality team and provides administrative, quality systems, and manufacturing documentation support. This position assists with maintaining controlled manufacturing documents and records, coordinating document changes and approvals, preparing quality and shipping documentation, and supporting Engineering, Quality, and Manufacturing activities as needed.

Essential Duties and Responsibilities

• Assist the Document Control Administrator with maintaining controlled manufacturing documentation, quality records, and associated paperwork.
• Process and manage document change requests in accordance with the company’s document control procedures.
• Make approved revisions to manufacturing documents and route revised documents to the appropriate managers, engineers, supervisors, and other stakeholders for review and approval.
• Coordinate the review, approval, issuance, distribution, and retention of manufacturing documentation.
• Assist Engineering and Quality personnel with developing and updating manufacturing instructions, procedures, forms, and other controlled documents.
• Take notes and photographs of manufacturing processes, equipment, and work areas to support requested document revisions.
• Generate and submit Certificates of Compliance, material certifications, and other customer or product-related quality documentation.
• Verify that manufacturing and quality records are accurate, complete, legible, and compliant with Good Manufacturing Practices and Good Documentation Practices.
• Perform filing, copying, scanning, collating, data entry, recordkeeping, and document archiving.
• Assist with maintaining electronic and hard-copy document control systems and records.
• Prepare local and international shipping paperwork for delivery services when required.
• Read and interpret engineering drawings, specifications, work instructions, and related manufacturing documentation.
• Work collaboratively with Quality, Engineering, Manufacturing, and other departments to resolve documentation questions or discrepancies.
• Complete all required training in accordance with the Biomerics training matrix.
• Work overtime or a flexible schedule periodically based on business needs.
• Perform additional duties and responsibilities as assigned by the supervisor.

Qualifications

• High school diploma or equivalent required.
• Minimum of one year of administrative, document control, quality, or manufacturing-related experience required.
• Three years of related experience is preferred.
• Experience working in a regulated manufacturing environment preferred.
• Knowledge of ISO 9001:2015 requirements preferred.
• Understanding of Good Manufacturing Practices and Good Documentation Practices.
• Working knowledge of NetSuite or a similar enterprise resource planning system preferred.
• Proficiency with Microsoft Office applications, including Word, Excel, Outlook, and related computer software.
• Ability to read and understand engineering drawings, specifications, and manufacturing documentation.
• Basic mathematical and statistical skills.
• Strong attention to detail and commitment to accuracy.
• Excellent organizational, time-management, and recordkeeping skills.
• Strong written and verbal communication skills.
• Ability to follow written and verbal instructions.
• Ability to work effectively as part of a cross-functional team.
• Ability to prioritize assignments and work with minimal direction when necessary.
• Ability to handle confidential or controlled information appropriately.
• Ability to adapt to changing priorities and meet established deadlines.