Quality Documentation Specialist

Job Description

Job Description

Job Summary

We are seeking detail-oriented Quality Documentation Specialists to support manufacturing and quality operations. The selected candidates will prepare, review, update, and maintain nonconformance reports using standardized templates and information from internal systems.

This role involves high-volume documentation, reviewing manufacturing and quality records, verifying information, and coordinating with different departments to ensure accurate and timely documentation.

Key Responsibilities

• Prepare and update nonconformance reports using standardized Microsoft Word templates.
• Document quality issues, problem descriptions, corrective actions, affected parts, lot numbers, quantities, and other relevant details.
• Retrieve and verify manufacturing, inventory, and quality information using Oracle and other internal systems.
• Review records for accuracy, completeness, and consistency.
• Coordinate with Quality, Manufacturing, Engineering, and Production teams to clarify missing or incorrect information.
• Make document revisions based on reviewer feedback and maintain accurate records.
• Track assigned, pending, in-progress, and completed documentation.
• Follow established quality procedures, documentation standards, and data integrity requirements.
• Ensure all documentation is accurate, organized, and completed within deadlines.

Required Qualifications

• Associate degree or equivalent combination of education and relevant experience.
• Minimum 1 year of experience in quality documentation, manufacturing, quality assurance, regulatory, compliance, or administrative support.
• Strong Microsoft Word skills, including formatting, templates, tables, and document editing.
• Working knowledge of Microsoft Excel, Outlook, and Teams.
• Ability to work with ERP systems such as Oracle and accurately manage information across multiple systems.
• Excellent attention to detail and written communication skills.
• Strong organizational, analytical, and problem-solving abilities.
• Comfortable handling repetitive, high-volume documentation work.
• Ability to follow established procedures and work independently after training.
• Good communication skills and ability to coordinate with multiple departments.

Preferred Qualifications

• Previous experience in quality documentation, document control, or manufacturing administration.
• Experience preparing or reviewing nonconformance reports, quality records, or regulatory documentation.
• Familiarity with medical device or other regulated manufacturing environments.
• Basic understanding of product specifications, plastic components, and manufacturing processes.
• Knowledge of GMP requirements and quality management procedures.

Physical Requirements

• Ability to work in a professional office/manufacturing environment.
• Comfortable sitting or standing for extended periods.
• Ability to occasionally lift or move objects weighing up to 25 lbs.
• Basic computer and office equipment proficiency.

Work Environment: Fully onsite, office-based role supporting manufacturing quality operations.