Pay Rate Low: 20 | Pay Rate High: 25

Job Summary

The Quality Documentation Coordinator manages important quality documents in a regulated (cGMP) environment. This includes organizing, tracking, storing, and retrieving records like batch records, test results, and Certificates of Analysis. 

Key Responsibilities

• Organize, track, file, and retrieve quality documents (both electronic and paper)

• Review batch records and Bills of Materials (BOMs)

• Send first production samples to customers and prepare shipping paperwork (FedEx/UPS)

• Release or place finished goods on hold in the ERP system (e.g., Access)

• Track and share documents with customers

• Help prepare quality issue reports

• Maintain safety records and ensure compliance with safety and cGMP standards

• Support audits and inspections by providing requested documents

• Identify documentation issues and help fix them

Qualifications

• High School Diploma or GED (required)
• 1-3 years of relevant experience in documentation, manufacturing, or quality assurance (preferably in a cGMP-regulated environment) (Preferred)
• MUST have knowlege of FDA documentation

This job description is a complete list of all desired skills, but not all are required. We strongly encourage candidates who have some of the skills to apply. We look forward to a conversation to learn more about you!

INDBH 
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