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ENSON LABORATORIES, INC is seeking a QA/QC professional to inspect raw materials and finished products, perform physical, chemical, and analytical testing, and ensure compliance with approved specifications and regulatory requirements. The role emphasizes meticulous documentation and adherence to GDP.
The ideal candidate holds a BS in Chemistry with QC laboratory experience, is licensed or registered as a chemist or chemical technician, and has familiarity with ISO 9001:2015, GMP, GLP, and
Inspect and test raw materials, packaging materials, intermediate products, bulk products, and finished products to ensure compliance with approved specifications, GMP, and regulatory requirements.
Perform laboratory analyses, including physical, chemical, and analytical testing, assays, and other quality control procedures using validated methods and laboratory instruments
Prepare and maintain quality control documentation, including specifications, sampling procedures, test methods, laboratory records, and Certificates of Analysis, ensuring compliance with Good Documentation Practices (GDP).
Maintain laboratory facilities, equipment, and instruments by ensuring cleanliness, proper operation, routine maintenance, calibration, and reporting any equipment malfunctions
Participate in validation activities, including equipment qualifications, analytical method validation, process validations, and other quality - related activities to ensure accuracy and reliability of test results
Comply with company policies, GMP, GLP, and regulatory requirements, report non - conforming results, support investigations and continuous improvement initiatives, and perform other duties as assigned by the QC Manager or Management
BS Chemistry with QC laboratory experience
Licensed/Registered Chemist or Chemical Technician
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.