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ENSON LABORATORIES, INC. is seeking a Quality Control leader to oversee laboratory operations across chemical, physical and microbiological testing of materials and products. The role focuses on ensuring methods and procedures meet approved specifications.
The incumbent will review results, approve COAs, maintain data integrity, and drive continuous improvement of QC systems while coordinating with various departments to support quality decisions.
Manages and oversees all Quality Control Laboratory operations, ensuring chemical, physical, and microbiological testing of raw materials, packaging materials, in - process materials, finished products, and stability samples are performed in accordance with approved specifications, analytical methods, and laboratory procedures.
Reviews, verifies, and approves laboratory results and quality documentation, including analytical reports and Certificates of Analysis (COAs), approves or rejects materials and products based on analytical findings, and ensures data integrity, confidentiality, and proper record retention.
Ensures compliance with GMP, GLP, regulatory requirements, and quality standards by establishing, implementing, and continually improving Quality Control procedures, specifications, test methods, laboratory systems, and supporting audits, inspections, supplier qualification, and management review activities
Leads and develop Quality Control personnel through work allocation, supervision, performance monitoring, competency assessment, training, and continuous professional development to ensure qualified and effective laboratory operations
Leads laboratory investigations and continuous improvement initiatives by investigating deviations, OOS, OOT, complaints, and non - conformances, implementing CAPA, reviewing quality trends, conducting validations, method verification, technology transfer, stability studies, and recommending improvements to laboratory systems and processes.
Ensures the effective management of laboratory resources and cross - functional coordination, by maintaining laboratory equipment, environmental conditions, facilities, reagents, reference standard, and testing supplies, while coordinating with Manufacturing, Production, Warehouse, Purchasing, Regulatory, and other departments to support quality decisions and laboratory operations
perform other duties as assigned