Quality Associate III

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!

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. This position is also eligible for relocation and a sign-on bonus!

Job Description

The Quality Associate III at an aseptic, sterile vial fill and finish manufacturing and packaging facility is responsible for the quality review and approval of protocols, reports, change controls, investigations, CAPAs and other compliance activities (i.e. APRs, stability reports, tech transfers) related to the plant operations.

ESSENTIAL AREAS OF RESPONSIBILITY

• Maintains work areas and performs job functions in a safe and efficient manner in accordance with company policies and procedures, Good Manufacturing Practices (cGMP’s), Standard Operating Procedures (SOP’s) and Batch Record instructions.
• Completes all training requirements and maintains 100% compliance with all assignments.
• Performs Quality review and approval of the change management process.
• Acts as SME of Root Cause Analysis (5 Whys, 6M’s, Is/Is Not, FMEA, etc) in support of writing, reviewing, and approving investigations to determine root cause and adequate corrective/preventive actions to prevent recurrence.
• Experience and mastery in technical writing for investigations, protocols, and reports in English language.
• Supports internal/external auditing.
• Reviews and approves work orders.
• Maintains metrics and drives improvement in areas related to the trends identified.
• Performs other duties as assigned.

Qualifications

• Bachelor’s degree in Science or related field from an accredited college or university is required.
• Minimum of 6 years of quality engineering or related QA experience in a cGMP manufacturing environment with at least 10 years in an aseptic/sterile environment.
• Requires experience with and an in-depth knowledge of cGMP and other applicable industry regulatory requirements as they relate to the production of pharmaceutical products and associated quality systems.
• Experience of Root Cause Analysis (5 Whys, 6M’s, Is/Is Not, FMEA, etc) in support of writing, reviewing, and approving investigations to determine root cause and adequate corrective/preventive actions to prevent recurrence.
• Experience in auditing techniques in a cGMP aseptic/sterile facility.
• Knowledge in Applied statistics and trend analysis such as SPC, Capability Analysis, and regression analysis.
• Knowledge of Lean/5s application.
• Requires experience with the handling of document review, report writing, metrics.
• Requires experience with writing investigations and change controls.
• Experience with Manufacturing/Quality systems such as Trackwise, LIMS/Labware, SAP and EDMS Systems.

Function

Sub Function

Reports To

Investigations Manager

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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.

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Empowering our diverse employee base and creating an inclusive culture is both a business imperative and an opportunity to bring us closer to our patients, our partners and our communities. Teva employees respect and embrace a diverse range of experiences, capabilities and perspectives that connect us to new insights and opportunities, while building a more inclusive culture for all. We strive to enable a work environment where all employees can feel engaged and know they are making an important contribution to improving health and making people feel better.