QA Inspector III - 3 Openings

Title: QA Inspector III - 3 Openings Location: On-site at Medina, NY Duration: 7 Months Hours: Monday - Friday: 5:30 am - 4:30 pm (OT as needed) Only W2 candidates are eligible for this position. Third-party or C2C candidates will not be considered. ESSENTIAL FUNCTIONS Perform the inspection of Device History Record (DHR) documentation for infusion pumps and wireless battery modules either on paper or in the electronic Manufacturing Execution System Camstar to ensure test procedures have been completed and release specifications are within specifications for final acceptance and release. Perform inspection of the pump or wireless battery module to ensure all visual aspects, including approved labels, are met prior to release of the pump or wireless battery module. Approve the release of the pump and wireless battery modules in the appropriate ERP system, as applicable (JDE B4ONE, JDE GME). Ensure there are no open nonconformances associated with the pump or wireless battery modules in the approved nonconformance tracking system. Review the device history log within a pump to ensure final testing has been completed in accordance with the applicable procedure. Accurately record all failing observations using the rework form in Camstar or the nonconformance system as applicable. Disposition of the rework activities of nonconformances and complete 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. Inspect Service Parts and approve release of the parts. Assist with the 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 detail 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. Must be able to sit for most of the workday. Ability to stand or walk for long periods as well. Must have good hand‑to‑eye coordination and dexterity. Dynamic lifting capability: Must have the ability to lift and carry 25 pounds. Must also have the capability to push and pull a maximum force of 5 pounds 4 feet. 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. 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. DivIHN is an equal opportunity employer. DivIHN does not and shall not discriminate against any employee or qualified applicant on the basis of race, color, religion (creed), gender, gender expression, age, national origin (ancestry), disability, marital status, sexual orientation, or military status. #J-18808-Ljbffr