Laboratory Services Quality Technician I

About CooperSurgical:

CooperSurgical is a leading fertility and women’s healthcare company dedicated to putting time on the side of women, babies, and families at the healthcare moments that matter most in life. As a division of CooperCompanies, we're driven by a unified purpose to enable patients to experience life's beautiful moments. Guided by our shared values – dedicated, innovative, friendly, partners, and do the right thing – our offerings support patients throughout their lifetimes, from contraception to fertility and birth solutions, to women’s and family care, and beyond. We currently offer over 600 clinically relevant medical devices to healthcare providers, including testing and treatment options, as well as an innovative suite of assisted reproductive technology and genomic testing solutions. Learn more at www.coopersurgical.com.

Job Summary:

Quality Control Lab Technician I role at Cord Blood Registry (CBR) is responsible for analyzing and documenting test results from our cord blood and cord tissue processed samples, releasing raw materials, supporting the analytical and processing equipment maintenance program, conducting environmental monitoring, and providing a wide range of critical functions that support the cryogenic storage of our client's final product. This position is also responsible for providing our internal customers with technical expertise while maintaining the highest quality services possible. The Quality Control Lab Technician I directly supports manufacturing to ensure the Product Operations function is provided with adequate equipment and materials to support stem cell processing activities. At the Technician I level, the individual performs critical daily activities involving high complexity testing, equipment maintenance and troubleshooting, interfacing with service providers, reagent testing, executing quality control assays and environmental monitoring activities. The role is also involved with supporting and executing validations, verifications, and projects within the Quality Control department. 

Essential Duties and Responsibilities:

• Adhere to CBR corporate and Quality Control policies 
• Ensure all work performed strictly adheres to CGLP/CGMP 
• Exercise Good Documentation Practices (GDP) 
• Use company Quality Management System (QMS), Laboratory Information System (LIS), equipment 
• management software, environmental monitoring software 
• Work in a biosafety level 2 (BSL-2) work environment 
• Complete and maintain records that meet regulatory requirements 
• Follow the laboratory's established policies and procedures whenever test systems are not within the laboratory's established acceptable levels of performance 
• Follow the laboratory's procedures for specimen handling and processing, reagent preparation, test analyses, reporting and maintaining records 
• Notify management and initiates discrepant events in the applicable quality system 
• Participate in training, projects, housekeeping, and other related activities 
• Train on a broad range of laboratory support functions and procedures as assigned, demonstrating expertise in technical skills and procedures within assigned discipline area (s) including analytical, bioanalytical and microbiological responsibilities 
• Provide support during peer training 
• Assist with lab investigations, deviations, corrective actions, procedure changes, method qualification planning, 
• etc. 
• Support Research and Development projects 
• Support the CBR stability program 
• Support material purchase ordering activities 
• Support material inspection and release activities 
• Support the everyday organization of the Microbiology laboratory activities including area cleaning, maintenance and ordering of supplies 
• Support biorepository activities 
• Handle Liquid Nitrogen (LN2) utilizing personal protective equipment and good safety practices Perform proficiency testing and participate in competency assessments 
• Perform equipment calibration, preventive maintenance and repairs 
• Perform data trending 
• Prioritize and organize work to deliver assignments according to established schedules and deadlines Communicate in a manner that fosters cooperation and creates a safe environment for those involved Provide audit preparation support activities 
• Familiarity with basic statistical tools to analyze data in relation to trends results 
• Capable of routinely multi-tasking 
• Problem solving and troubleshooting 
• Make informed and timely decisions independently 
• Apply common sense understanding when working independently on departmental projects, timelines and dealing with compliance issues 
• Wear appropriat