Quality Control Laboratory Technician II

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. CooperSurgical is at the forefront of delivering innovative assisted reproductive technology and genomic solutions that enhance the work of ART professionals to the benefit of families. We currently offer over 600 clinically relevant medical devices to women's healthcare providers, including testing and treatment options.

 CooperSurgical is a wholly-owned subsidiary of CooperCompanies (Nasdaq: COO). CooperSurgical, headquartered in Trumbull, CT, produces and markets a wide array of products and services for use by women's health care clinicians. More information can be found at www.coopersurgical.com.

Quality Control Technician II directly supports Operations by performing inspections and testing for quality assurance. The Technician contributes and adheres to all QC processes and procedures. Daily activities for this role include material inspections, high complexity testing, equipment maintenance and troubleshooting, interfacing with service providers, process monitoring, executing quality control assays, environmental monitoring, and preparing quality documentation. This role is routinely involved in executing tests and reporting results for inspections, validations, verifications, and investigations. The individual will demonstrate excellence by representing Quality Control in supporting key processes. 

Essential Functions & Accountabilities:

• Adhere to 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 
• Accurately complete and maintain records that meet regulatory requirements 
• Perform quality control testing and inspections
• Perform material inspection and release activities
• Coordinate and perform equipment calibration, preventive maintenance and repairs 
• Perform in-process monitoring and data trending 
• Perform equipment Installation, Operation and Performance Qualifications (IQ/OQ/PQ) 
• Perform environmental monitoring (EM) activities
• Respond to environmental monitoring alarms
• Prepare reports and certificates for tests and inspections
• Follow the laboratory's established policies and procedures whenever test systems are not within the laboratory's established acceptable levels of performance 
• Notify management of deviations and initiate deviation/nonconformance process in the applicable quality system 
• Assist with lab investigations, deviations, corrective actions, change control, method qualification planning, etc. 
• Provide audit preparation support activities 
• Provide administrative support: copying, filing, and archiving records 
• Support the everyday organization of laboratory activities including area cleaning, maintenance and ordering of supplies 
• Work in a biosafety level-2 (BSL-2) work environment 
• Wear appropriate Personal Protective Equipment (PPE)  
• Follow the laboratory's procedures for specimen handling and processing, reagent preparation, test analyses, reporting and maintaining records  
• Train and maintain competence on a broad range of laboratory support functions and procedures as assigned, demonstrating expertise in technical skills and procedures within the assigned discipline area(s) including analytical, bioanalytical and microbiological responsibilities 
• Coordinate proficiency testing and participate in competency assessments. 
• Provide support during peer training
• Participate in training, projects, housekeeping, and other related activities 
• Support Research and Development projects 
• Support method development, qualifications, and validations   
• Support material purchase ordering activities 
• Support inventory monitoring and control activities
• 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 
• Familiarity with basic statistical tools to analyze data in relation to trends results 
• Capable of routinely multi-tasking  
• Problem solving and troubleshooting competencies 
• Make informed and timely decisions independently
• Maintain confidentiality
• Apply common sense understanding to carry out instructions furnished in written, oral, or diag