Quality Systems Specialist (Temporary Assignment)

Job Description

Job Description

Job Summary
Quality Systems Specialist supports the cGMP Document Control and Training function and ensuring compliance with FDA 21 CFR, ISO 13485, and ICH Q10 standards. This position supports the maintenance of documentation required for Good Manufacturing Practices (cGMP) and contributes to regulatory compliance activities across departments including Production, Quality Control, Packaging, Warehousing, and Distribution.

This role focuses on executing routine document control and training activities such as filing, scanning, tracking, and distributing controlled documents while ensuring accuracy, version control, and accessibility of quality system records.

Key Responsibilities

Document Control
• Issue and distribute controlled documents (e.g., SOPs, manufacturing instructions, logbooks) to appropriate departments.
• Scan, file, and maintain both paper and electronic records, ensuring organization of physical filing systems and digital Document Management Systems in accordance with company procedures.
• Manage record retention activities, including coordination of offsite storage.
• Maintain QA logs to ensure timely completion and accuracy.
• Issue and track laboratory notebooks.
• Print, distribute, and securely transmit documents as required.
• Assist cross-functional teams in locating and accessing documents.
• Perform completeness checks on change control documentation to ensure required information and approvals are included

Training
• Assist with maintaining training files to ensure records are complete, accurate, and audit-ready.
• Support training documentation completeness checks and follow up on missing or outdated records.
• Help keep training data current by updating records in the training database or eQMS.
• Provide support in tracking training completion and identifying overdue items.
• Assist with generating routine training reports for compliance and audit purposes.

Education and experience
• Bachelor’s degree in a scientific, technical, or related field preferred.
• 1 – 3 years of experience in a document control, Quality Systems, and a cGMP environment preferred.
• Basic understanding of FDA 21 CFR, ISO 13485, or similar regulatory standards is a plus.

Requirements and Skills
• Strong attention to detail and accuracy in document handling.
• Excellent organizational and time management skills.
• Strong written and verbal communication skills.
• Ability to manage multiple priorities in a fast-paced, project-driven environment.
• Team-oriented with the ability to collaborate across departments.
• Ability to follow procedures while exercising sound judgment.
• Proficiency in Microsoft Office (Word, Excel, Outlook).
• Familiarity with document control processes and training systems.
• Experience with document management systems (eQMS such as Dot Compliance preferred).

Physical Requirements
• Prolonged periods of sitting at a desk and working on a computer
• Occasional standing for extended periods.
• Must be able to lift up to 20 pounds at times.

Compensation : $46/hour.