27 days old

Quality Associate II

Irvine, CA 92606
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 Quality Associate II Quality Systems to join our team in Irvine, CA!
This position is primarily responsible for supporting QA review and processing document changes and change controls within the Electronic Document Management Systems (EDMS) and TrackWise system. The QA Analyst II routinely monitors performance through metrics and analysis of sites quality systems (i.e., Document Changes, Change Controls, Deviations, CAPAs) to identify trends/patterns for items such as right first time, on time completion, and frequency of occurrence.
 You will:

  • Conduct QA review and approval of activities associated with changes to master documents, procedures, and ensure compliance and adherence to local SOPs, 21 CFR requirements Partner with other teams at various levels of the organization to ensure timely and accurate completion of follow-up activities including overseeing timeline, collecting documentation, providing guidance as subject matter expert, etc.
  • Track, analyze and report on relevant metrics and tracking logs to ensure team and site are meeting or exceeding KPIs established by global team and site leadership.
  • Lead and/or participate in ongoing and new quality, compliance process improvement, and product transfer/launch initiatives (e.g. improving cycle time and quality of document changes/ change controls).
  • Provide new employee training for document change and change control processes.
  • Will be subject matter expert for EDMS and TrackWise for change controls supporting internal and external audit activities as well as writing and/or reviewing/approving investigations, cGMP documents, processes, etc. in a thorough, compliant and timely manner.
  • Maintain work areas and perform job functions in a safe and efficient manner in accordance with company policies and procedures, Good Manufacturing Practices (cGMPs), Standard Operating Procedures (SOPs) and Safety Requirements.
  • Bachelors degree preferred. Equivalent education/experience may be accepted in lieu of degree.
  • ASQ Certification preferred.
  • Five years related QA experience in a Pharmaceutical manufacturing environment required.
  • Experience working in a Sterile Aseptic manufacturing environment strongly preferred.
  • Experience with and an in-depth knowledge of cGMP and other applicable industry regulatory requirements related to production of pharmaceutical products and associated quality systems preferred.
  • Experience with and in-depth knowledge of document changes, change controls, deviation investigations and CAPAs required.
  • Experience with Manufacturing/Quality systems such as TrackWise. Experience with a Learning Management System and LIMs preferred.
  • Computer proficiency with comprehensive working knowledge of MS Office products, ERP system such as SAP or Oracle.
  • Detail oriented with ability to identify errors or inconsistencies while performing tasks and to solicit or initiate corrective responses. Ability to demonstrate sound judgment and decision-making.
  • Ability to build and maintain collaborative relationships between teams, departments and business units. Motivate and influence others without direct authority.
  • Self-directed with ability to organize and prioritize work with little instruction on routine work and under general instructions on new projects.
  • Ability to communicate effectively with excellent written and oral communication skills.
Sub Function
Quality Compliance
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: 2020-03-06 Expires: 2020-04-15

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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Quality Associate II

Teva Pharmaceuticals
Irvine, CA 92606

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