10 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:

  • Lead/manage action plans proactively for needed improvements to minimize consumer and compliance risk, and participate in investigations and internal audits with potential to lead investigations. 
  • Become SME for EDMS and TrackWise for change control and back up other elements within the sites quality systems such as Learning Management Systems, LIMS, and/or Oracle/SAP. Ensure the health of these systems minimally meet the KPIs established by the global team and site leadership.
  • Conduct QA review and approval of activities associated with changes to master documents, procedures, and ensure compliance and adherence to local SOPs and 21 CFR requirements while leveraging ICH Q9 and Q10.
  • Monitor major quality systems to ensure timely completion activities and execute follow-up activities with outside departments to provide timely execution of investigation and changes.
  • Compile and maintain metrics and tracking logs and successfully hit metrics delivery schedules.
  • Write and/or review/approve investigations, cGMP documents, processes, etc. in a thorough and timely manner.
  • Lead ongoing and new quality, compliance and process initiatives at the site (i.e. improve cycle time and quality of document changes, deviations, change controls).
  • Support or act as QA lead on product launches and related document reviews/approvals including change control items, protocols, batch records and deviations.
  • Provide support and guidance to others within Quality (i.e. Quality Control, Compliance) and other departments and provide new employee training for document change process and change controls.
  • Complete all training requirements and maintain 100% compliance with all assignments. 
  • 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 Batch Record instructions.
  • 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 and statistical software JMP or Minitab highly preferred. 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: 2020-02-06 Expires: 2020-03-07

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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