VIVA USA Inc QA Technician in Medina, New York
Req Ref No: LSNYFQ811 Location: Medina, NY Duration: 6.0 months Description Description: Final QA Technician I. SUMMARY: This document outlines the employment prerequisites and job responsibilities for the Inspector, Final QA position II. ESSENTIAL FUNCTIONS: ? Perform the inspection of ICL documentation for infusion pumps (devices) and wireless battery modules either on paper or in the electronic Global Service Platform (GSP) system in order to ensure test procedures have been completed and release specifications are within specifications for final device acceptance and release. ? Perform internal inspection of devices to ensure all visual aspects of the pump or wireless battery module, including approved labels, are met prior to release of device or wireless battery module. ? Verify that all customer facing device and packing labels are accurate and match the serial number being inspected. ? Approves the release of the device and wireless battery modules in the appropriate ERR system, as applicable (JDE B4ONE, JDE GME) ? Ensures there are no open nonconformances associates with device or wireless battery modules exist in the approved NCR system (QCBD, Trackwise). ? Reviews the event history log within a device to ensure calibration values have been accurately entered in the pump using release testing values recorded in GSP. ? Accurately record all failing observations using the minor correction process and/or electronic nonconformance system (QCBD or Trackwise) as applicable. ? Dispositions the rework activities of nonconformances and completes the electronic approval and closure process for any non-conformances with the device in the approved electronic system. ? Ensure process control and maintenance procedures are being followed. ? Recognize out of compliance/out of tolerance situations and take appropriate action. ? Adding QA flags to all received product using the appropriate ERP system (JDE B4ONE) ? Inspect and perform QA release activities of Spare Parts Kits. ? Assist with identification and containment of nonconforming product on the floor for internal investigations and holds. ? Perform other duties as assigned. QUALIFICATIONS, KNOWLEDGE AND SKILLS REQUIRED: ? Knowledge and working application of the following: ? Measurement equipment. ? cGMP documentation and FDA ? Basic ESD requirements ? Computer based programs ? Data entry and spreadsheet applications. ? Perform repetitive motions with hands/fingers. Demonstrated attention to details and accuracy, required. ? Must have good communication skills. ? May be required to work flexible hours and overtime on short notice. ? Ability to visually inspect and identify particulate/foreign matter and distinguish between colors as required by FDA Current Good Manufacturing Practices EDUCATION/EXPERIENCE REQUIRED: ? High School diploma or GED ? Preferred experience in a pharmaceutical or Biotech industry helpful. ? Must be familiar with cGMP and FDA requirements. PHYSICAL DEMANDS: The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of the job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. While performing the duties of this job, the employee: ? Must be able to sit for most of the work day. ? Ability to stand or walk for long periods as well. ? Must have good hand to eye coordination and dexterity WORK ENVIRONMENT: Work environment characteristics described here are representative of those that must be met by an employee to successfully perform the essential functions of the job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. This is a manufacturing environment regulated by the FDA and many other work rules to prevent damage to the product we manufacture. Some of those work rules include but are not limited to: ? Wearing a static protective smock at all times while in the work area ? Wearing a ground wrist strap and plugging that wrist strap into the working table if at an ESD sensitive station. ? Working in close proximity to other employees. ? Working in an environment that is temperature and humidity controlled. Note : Hours: M-Th (10 hours); OT on Friday and Saturday as needed VIVA is an equal opportunity employer. All qualified applicants have an equal opportunity for placement, and all employees have an equal opportunity to develop on the job. This means that VIVA will not discriminate against any employee or qualified applicant on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.