QA Inspector
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Overview
Remote
On-site
Compensation
$26-$26/hour
Job Description
Title: QA Inspector Location: Medina, NYContract: 5 monthsShift: Monday- Thursday: 5:30am- 4:00pm OT as needed on Friday Pay Rate: $26/Hour on W2Essential 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 Cam star 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.
- Approves the release of the pump and wireless battery modules in the appropriate ERP system, as applicable (JDE B4ONE, JDE GME)
- Ensures there are no open nonconformances associated with the pump or wireless battery modules in the approved nonconformance tracking system.
- Reviews the device history log within a pump to ensure final testing has been completed in accordance to the applicable procedure.
- Accurately record all failing observations using the rework form in Cam star or the nonconformance system 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.
- Inspect Service Parts and approve release of the parts.
- Assist with identification and containment of nonconforming product on the floor for internal investigations and holds.
- Perform other duties as assigned.
- 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.
- High School diploma or GED.
- Preferred experience in a pharmaceutical or Biotech industry helpful.
- Must be familiar with cGMP and FDA requirements.
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FAQs About QA Inspector Jobs at Integrated Resources, Inc
What is the work location for this position at Integrated Resources, Inc?
This job at Integrated Resources, Inc is located in Medina, NY, according to the details provided by the employer. Some roles may also include multiple work locations depending on the requirement.
What pay range can candidates expect for this role at Integrated Resources, Inc?
Candidates can expect a pay range of $26–$26 per hour for this role.
What employment applies to this position at Integrated Resources, Inc?
The employer has not provided this information. This may be discussed during the hiring process.
What is the process to apply for this position at Integrated Resources, Inc?
You can apply for this role at Integrated Resources, Inc either through Sonara's automated application system, which helps you submit applications 10X faster with minimal effort, or by applying manually using the direct link on the job page.