Quality Control Associate

Quality Control position to join a commercial stage Biotech. 5 days onsite in NYC. At this time the company cannot offer sponsorship, and the successful candidate will need to be a US citizen.

• Coordinate sample shipment, log and track testing submission at CTO and collate assay results.
• Review QC data for accuracy and completeness
• Maintain quality databases.
• Review documentation such as shipment receipt and release for quality assessment
• Prepare and manage quality documentation, such as SOPs, deviations, change controls related to QC

• Prepare quality documentation in a timely manner for review and approval by QA Management to support lot disposition
• Manage metrics for QC data turnaround times

• Track invoices in relation to testing at CTOs
• Proactively communicate status, key issues, and any other critical topics in a timely manner to the appropriate management level and relevant project team member(s)

• Bachelor’s degree or higher in a life science or related discipline
• Experience working in a regulated GxP compliant environment preferred
• Experience with quality systems and regulatory compliance in the pharma or biotech industry preferred

• Able to handle and coordinate multiple projects/activities and interface with other departments and at different levels
• Ability to work in a fast-paced environment in a results oriented fashion
• Highly organized
• Sound decision making abilities
• Demonstrates initiative
• Strong written and verbal communication skills