Quality Coordinator
Core
Coordinates quality activities for a designated Customer Focused Team to ensure goals and objectives are met within timeframes and budget, driving project success in long-term quality customer management.
Role type
Quality Coordinator
Builds
Batch records, forms, material specifications, and documentation for product release
Domain
Biopharma manufacturing / Quality Assurance
Required skills
Documentation review, batch record creation, cGMP compliance, data interpretation, problem identification, customer communication, metric reporting, finished product batch release
Preferred skills
Operations/Quality support experience, attention to detail, professional demeanor, instruction following
Technologies
Computer programs for complex tasks
Responsibilities
Prepare and distribute documentation for production work orders; Review completed orders for cGMP and customer compliance; Create and update batch records and material specifications; Submit batch records and accountability reports to customers; Resolve document-related issues with departments and customers; Provide quality-related metrics; Perform finished product batch release; Meet with management to address documentation issues; Interpret customer standards and procedures.