Laboratory Quality Control Technician II

at  The Cooper Companies

P
e
rform quality control tests for Media raw materials, intermediate and final products, as well as laboratory internal controls. Perform environmental monitoring sampling and testing. Follow Good Laboratory Practices, Good Manufacturing Practices, Good Documentation Practices, and safety measures, assuring best practices for reliability of results.Qu

OWLEDGE, SKILLS AND ABILITIES:CO

• mprehend and apply written instructions, specifications, and methods in both English and Spanish.En
• glish intermediate level, read and write technical documents.Kn
• owledge of GLP’s, GDP´s is a plus.De
• tail oriented, eager to learn, effective time management, adaptability to change, team working, proactive, and open to escalate concerns on time.Wo

SENTIAL FUNCTIONS & ACCOUNTABILITIES:EX

• ecutes analysis on raw materials for Incoming Quality, intermediate and finished goods for Final Release.Ex
• ecutes laboratory internal controls.Co
• llaborates with the test required as part of equipment qualification and method validations.Te
• sts to be performed may include bioburden and sterility testing, filter integrity test, pH, osmolality, viscosity, endotoxin test, microbiological control as environmental monitoring, plate reading and general assays for microorganisms’ identification.Re
• cords results on inspection forms and reports. Maintains department files for readily retrievable access of records.No
• tifies designated supervisor or engineer when result exceeds acceptable limits or when major incidents are noted.Co
• ordinates external testing, samples shipment, tracking and test results report, review.Pe
• rforms tasks under Good Manufacturing Practices (GMPs), Good Laboratory Practices (GLP), Good documentation Practices (GDP), safety techniques and aligned with the regulatory standards such as USP, ACS, Ph. Eur, ASTM for laboratory testing and improvements.Pe
• rforms environmental monitoring sampling and testing or coordinates with contractors when required.Co
• llaborates with Lean initiatives such as 5S and Gemba walks.Co
• llaborates with inventory tracking and notifies the supervisor to maintain the stock of materials.Co
• llaborates in training of new personnel in specific testing when required.Ex
• ecutes cleaning activities to maintain order and disinfection of specific areas.Pe
• rforms equipment user´s preventive maintenance and documents appropriately.Co
• llaborates in documentation improvement, such as SOPs, forms, or logbooks.Co
• llaborates in continuous improvement of laboratory operations.Su

Please refer the Job description for details