Quality Assurance, Data Entry Clerk

Quality Assurance, Data Entry Clerk

Position Summary

The Quality Assurance Clerk is responsible for maintaining and organizing critical quality documentation to support FDA compliance, internal quality systems, and customer audits. This position ensures that quality records, batch documentation, and archived files are accurately scanned, copied, filed, and readily retrievable. The ideal candidate is highly organized, detail-oriented, and committed to maintaining document accuracy in a regulated GMP environment.

Compensation

Pay Rate: $18.00 - $20.00 per hour, based on experience and qualifications.

Essential Duties and Responsibilities

• Photocopy, scan, and organize quality documents, batch records, and controlled records.
• File quality documentation accurately to ensure immediate retrieval during FDA, customer, and internal audits.
• Maintain document organization in accordance with company document control procedures.
• Support Quality Document Workflow (QDW), Sample Tracking Workflow (STW), Trial Master File (TMF), and Batch History Record (BHR) archival activities.
• Assist departments with document copying, scanning, filing, and record retrieval.
• Perform routine document audits to verify record completeness, accuracy, and filing compliance.
• Maintain confidentiality and integrity of controlled quality documentation.
• Assist with records retention and archival processes.
• Support Quality Assurance projects and administrative activities as assigned.
• Perform other duties as assigned.

Qualifications

Required Education

• High school diploma or equivalent required.

Preferred Qualifications

• Previous experience in document control, records management, quality assurance, or administrative support preferred.
• Experience working in a GMP, FDA-regulated, pharmaceutical, biotechnology, or medical device environment is a plus.

Required Skills & Competencies

• Exceptional attention to detail and organizational skills.
• Strong document management and filing abilities.
• Ability to maintain accuracy while handling large volumes of documentation.
• Basic computer proficiency, including Microsoft Office (Word, Excel, Outlook).
• Strong communication and teamwork skills.
• Ability to prioritize multiple tasks in a fast-paced environment.
• Ability to maintain confidentiality of sensitive documentation.
• Dependable with a strong sense of ownership and accountability.

Physical Requirements

• Ability to stand for extended periods while copying, scanning, and filing documents.
• Ability to lift and move boxes of records weighing up to 25 pounds.
• Frequent bending, reaching, walking, and filing throughout the workday.

Work Schedule

This is a full-time position.

Schedule:

• Monday through Friday
• 8:00 AM – 5:00 PM
• Overtime may be required based on business needs.

Work Environment

This position is performed in an office and manufacturing environment supporting Quality Assurance operations. The role requires frequent interaction with controlled documentation and adherence to FDA, GMP, and company quality procedures.

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