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Quality Compliance Associate

Date: Jan 13, 2022

Location: Irvine, California, US, 00000

Company: Teva Pharmaceuticals

Company Info

If you’re like people at Teva, you dare to be different. We’re making well-being a way of life for our customers and our colleagues. Join us in helping to make healthcare more accessible to more patients, while supporting one of the most innovative teams in the industry. Teva’s Irvine, CA production site is one of our complex manufacturing and supply chain operations. We are strengthening and adding to our critical teams with great talent and capabilities. Teva, a global organization, with a brand of evolving success.  Be part of it!

 

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!

 

We offer a competitive benefits package including Medical, Dental, Vision and Prescription coverage starting on the first day. We also offer Disability and Life Insurance, Paid Time Off, 6% match on the 401(k), Employee Stock Purchase Plan and Tuition Assistance.

Job Description

Teva is searching for a Quality Compliance Associate to join our Quality Compliance team in Irvine, CA! 


In this role, you will:
•    Co-Lead internal audits for the site’s compliance to GMP regulations, collaborate with departmental stakeholders to oversee that needed actions are addressed in a timely fashion.
•    Facilitate the site’s routine gap assessment process between new/updated corporate standards and site procedures.  
•    Drive timely input from departmental stakeholders for conducting gap assessments and completing subsequent CAPAs to close identified gaps.
•    Inform 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.
•    Participate and take active role in regulatory inspections and communications.
•    Work with subject matter experts to keep the site inspection-ready, organizing resources and materials, and provide input on correspondences with the regulatory authorities.
•    Support Supplier Quality Management and collaborate with stakeholders working to qualify new suppliers, new materials, and GMP vendors for the site.
•    Conduct periodic reviews of established suppliers, ensure appropriate updates per management of change process. 
•    Establish and renew Quality Agreements with suppliers, monitor supplier audit results/responses.
•    Write and peer-review investigations, risk assessments, and root cause analysis related to product post-market surveillance and complaints.
•    Participate in monthly and quarterly routines for the site’s compliance, including the site’s quality council, annual product reviews and related sub-reports, and various trending reports.

Qualifications

•    BA degree in related science, engineering or similar required
•    5 years QA or Compliance experience in a highly regulated environment required.
•    5 years of technical writing experience required
•    2 years working in Sterile / Aseptic operating environment is required
•    2 years of experience working on GMP compliance, data integrity, auditing, investigations, CAPAs, and change management required

Function

Quality

Sub Function

Quality Compliance

Reports To

Assoc Dir, Compliance 

Already Working @TEVA?

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Teva’s Equal Employment Opportunity Commitment

Teva Pharmaceuticals is committed to equal opportunity in employment. It is Teva's global policy that equal employment opportunity be provided without regard to age, race, creed, color, religion, sex, disability, pregnancy, medical condition, sexual orientation, gender identity or expression, ancestry, veteran status, national or ethnic origin or any other legally recognized status entitled to protection under applicable laws. We are committed to a diverse and inclusive workplace for all. If you are contacted for a job opportunity, please advise us of any accommodations needed to support you throughout the recruitment and selection process. All accommodation information provided will be treated as confidential and used only for the purpose of providing an accessible candidate experience.