1+ months

Senior Quality Associate (Visual Inspection - liquids)

Irvine, CA 92606
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Company Info
Teva is a global pharmaceutical leader and the world's largest generic medicines producer, committed to improving health and increasing access to quality health solutions worldwide. Our employees are at the core of our success, with colleagues in over 80 countries delivering the world's largest medicine cabinet to 200 million people every day. We offer a uniquely diverse portfolio of products and solutions for patients and we've built a promising pipeline centered around our core therapeutic areas. We are continually developing patient-centric solutions and significantly growing both our generic and specialty medicines business through investment in research and development, marketing, business development and innovation. This is how we improve health and enable people to live better, healthier lives. Join us on our journey of growth!
Job Description

Teva is searching for a Sr Quality Associate (visual inspection) to join our team in Irvine, CA!

 

This position is responsible for overseeing the quality and compliance of the sites visual inspection program and inspector certification.  You will ensure the quality and compliance of the sites visual inspection program, inspector certifications, defect library, and test kits and be the subject matter expert for the visual defect test kit populations and visual defect library. Partner with other departments for continuous improvement of the lifecycle management for the reduction of particulate matter and visual defects with components and inspected finished goods

 

You will:

  • Oversee Inspector Certification Program (ICP) by creating, assembling maintaining the visual inspection test Kits.
  • Conduct certification training and examinations for annual certification of visual inspectors.
  • Provide assistance with related product investigations and particulate matter reduction lifecycle management efforts by utilizing the sites defect library, your technical knowledge, and collaboration with production and internal and external laboratories. 
  • Administer and provide feedback during inspector certification and re-certification exams.
  • Work with outside vendors to acquire and maintain defect samples of test kit populations.
  • Analyze and review the purchased standards from vendors to verify the presence of particles and container-closure defects prior to use.
  • Analyze and perform assessment the existing ICP populations to verify presence of all defects and replace existing population or create a new population as needed, in addition to updating all required documentations.
  • Analyze and assess the Defect Library for visual inspection annually or as needed and update defects as needed.
  • Review routine monitoring of visual inspection rates in production and check individual accuracy with periodic tray audits Assist with spot-checking routine production for compliance to visual inspection requirements.
  • Initiate Production Test Run Authorization (PTRA) as needed to facilitate acquiring materials needed for creating new defect samples.
  • Collaborate on investigations related to visual inspection criteria and observed defects, as well as on projects to help improve the lifecycle management approach to particulate matter and visual defects
  • Perform training on visual inspection procedures, inspection techniques, and defect types.
  • Write, review and revise existing SOPs procedures and Protocols procedures.
Qualifications
  • 4-year degree in science, engineering, or relevant field required.
  • Minimum of 5 years of FDA regulated quality experience.
  • 7 or more years of pharmaceutical or medical device manufacturing experience preferred.
  • Good written and verbal communication skills, Experience with office computer programs; statistical data review and related software experience a plus.
  • Must be able to do gowning and environmental monitoring to enter ISO clean rooms.
  • Must be able to pass vision exam and maintain certification annually in the Inspector Certification Program.
  • This role requires the ability to have vision correctable to 20/20 for near and distance, normal color vision and normal depth perception.
  • This role requires prolonged standing and lifting up to 25 lbs.
Function
Quality
Sub Function
Quality Assurance Methods
Already Working @TEVA?

If you are a current Teva employee, please apply using the internal career site available on "Employee Central". By doing so, your application will be treated with priority. You will also be able to see opportunities that are open exclusively to Teva employees. Use the following link to search and apply: Internal Career Site

The internal career site is available from your home network as well. If you have trouble accessing your EC account, please contact your local HR/IT partner.

Posted: 2020-06-23 Expires: 2020-10-28

Join us at the forefront of pharmaceutical research and production. With state-of-the-art facilities, highly skilled colleagues, and a high-powered organizational culture, Teva offers you countless possibilities to make a real difference in people's lives and add value to your career.

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Senior Quality Associate (Visual Inspection - liquids)

Teva Pharmaceuticals
Irvine, CA 92606

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