Associate Document Control Administrator

About the Role

The primary purpose of this position is to support and perform documentation administration activities within the Quality function, adhering to Good Manufacturing Practices (GMP) and Quality system guidelines. Carries out responsibilities under clearly defined procedures and / or under close supervision.

Key Responsibilities

• Adhere to company policies and procedures and all safety and quality requirements including, but not limited to: Quality Management Systems (QMS), Environmental and Security Management Systems (EMS), U.S. Food and Drug Administration (FDA) regulations, Company policies and operating procedures, and other regulatory requirements.
• Provide administrator support for change record implementation in line with standard operating procedures.
• Control distribution and retrieval of documents including electronic files of controlled documents.
• Notify applicable functions when local external documents change.
• Manage and control access to on-site and off-site records and documents.
• Perform annual record disposition review.
• Compile / complete quality records, reports and / or documentation ensuring Good Documentation Practices (GDP) are applied.
• Review Device History Record (DHR) in accordance with applicable procedures and Good Documentation.
• Assist the Quality department during audits.
• Performs other duties as required.
• Continually seeks to drive improvements in process quality.
• Identifies and escalates quality non-conformances to assist in achieving company quality objectives and key business metrics.
• Embed Quality within your daily work life.

Requirements & Tech Stack

• General computer operation skills (e.g., Microsoft Teams, Excel, Word)
• Basic understanding of Electronic documentation systems
• Office management and administration skills

Qualifications

• Minimum Education: High school graduate or equivalent may be required.
• Minimum Experience: 0-1 years of experience in entry level administrative duties.
• Capable of working under close supervision.
• Leadership
• Accountable for own contribution
• Effective communication skills (both oral and written).
• Uses basic communication skills.
• Strong organizational skills (including time management and ability to prioritize and meet deadlines).
• Attention to detail when reviewing and preparing documents.
• Problem Solving
• Use existing procedures to solve problems and engage in continuous improvement activities.
• Knowledge of Quality Management Systems (e.g., ISO 9001, ISO13485, FDA 21 CFR Part 820)