Documentation Control Specialist
Quality Assurance
Roanoke, Virginia, US
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!
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We are an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability status, protected veteran status, or any other characteristic protected by law.