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ENSON LABORATORIES, INC is seeking a Quality Control Manager to oversee all QC 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.
You will review results and COAs, ensure data integrity, and lead GMP/GLP compliance initiatives, audits, and trainings.
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 develops 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 standards, and testing supplies, while coordinating with Manufacturing, Production, Warehouse, Purchasing, Regulatory, and other departments to support quality decisions and laboratory operations
Qualifications
Preferably Graduate of BS Chemistry
Licensed/Registered Chemist
With experience in laboratory testing or manufacturing is an advantage
With knowledge and familiarity in ISO 9001:2015 Quality Management System, GMP, GLP, and quality control procedures.