9 days old

Senior QA Associate (Quality Compliance)

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 Senior QA Associate (Quality Compliance) to join our team in Irvine, CA! 


In this role, you will:

  • Lead internal audits for departmental compliance to GMP regulations and occasional off-site audits of critical suppliers.  Establish and renew Quality Agreements with critical suppliers and service providers.
  • Notify senior leadership and corporate leaders of critical compliance issues through the escalation procedure; orchestrate activities related to field alerts, market action decisions, and related corrective activities.
  • Conduct gap assessments between corporate standards and site procedures, as well as to new regulations or for new global market registrations.
  • Manage the cross-contamination risk assessment process evaluating the risks to the sites product portfolio and facilities
  • Write and peer review investigations, risk assessments, and root cause analysis related to product post-market surveillance and complaints.
Qualifications
  • 6+ years QA experience in a highly regulated environment required. 2+ years experience working in an FDA regulated environment/industry strongly preferred
  • Experience working with multiple global regulatory agencies a plus
  • BA degree in related science, Engineering or similar required
  • Experience working in a Pharmaceutical production environment strongly preferred.
  • Sterile / Aseptic and Biologics environments experience preferred
  • Excellent communication and collaboration skills, verbal and written and presentation skills required.
  • Technical writing experience required, and the ability to articulate technical concepts to non-technical people
  • Demonstrated experience as SME around investigations, CAPAs, change requests, GMP compliance and execution of SOPs required
  • Ability to self-motivate combined with the ability to deal with ambiguity
  • Willingness to learn; ability to assist with data research and to find information
  • Process improvement mindset required, including being comfortable asking questions, willingness to question the status quo
     
Function
Quality
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.

Categories

Posted: 2020-02-07 Expires: 2020-03-08

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 QA Associate (Quality Compliance)

Teva Pharmaceuticals
Irvine, CA 92606

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