Sr Associate II, Quality Control Investigator

Role Summary

The Sr Associate II will support and lead team initiatives regarding compliance, documentation, writing deviations, lab exceptions, actions, and environmental excursions. The Sr Associate II must have practical knowledge of current regulations and cGMPs to ensure all work is performed in a cGMP manner, with adherence to regulatory regulations.

Responsibilities

• Investigate discrepancies and capture activities in writing. Ensure appropriate corrective actions are captured, as applicable, for laboratory deviations and exceptions
• Author technically sound moderately complex reports with minimal guidance
• Support laboratory operations, to include QU, and actively and effectively communicate across functional groups and levels for completion of deliverables
• Initiate and monitor QC laboratory documentation, such as Standard Operating Procedures and periodic review of laboratory procedures and see them through to completion
• May provide Quality Unit (QU) approval for minor deviations, lab logbooks, and Analytical Instrument Validation (AIV) reports
• Participates in process improvements, supports management and QC teams
• Other duties as assigned

Qualifications

• Required: Bachelor’s degree, preferably in a field of science or biotechnology
• Required: A minimum of 5 years’ relevant experience in quality oversight of a biotechnology or pharmaceutical manufacturing operation
• Required: Thorough understanding and demonstrated expertise in conducting investigations in a biotech or pharma GMP environment within Quality Control labs
• Required: Good working knowledge of operations/quality systems understands work processes of QC operations/support teams (e.g., strong test method/scientific base)
• Required: Excellent technical writing skills; authors technically sound, simple to moderately complex reports and complex reports with limited guidance
• Preferred: Proficient in Trackwise, LabWare, LIMs, Kneat, and Veeva

Education

• Bachelor’s degree, preferably in a field of science or biotechnology