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Quality Analyst II

Date: Jun 22, 2022

Location: Davie, Florida, US, 33314

Company: Teva Pharmaceuticals

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.

Job Description

The Quality Analyst II is responsible for coordinating and completing annual product reviews, prepare reports, and analyzing data. The Analyst will monitor and trend key areas and indicators from production and laboratories for implementation of corrective and preventative measures.

 

Essential Responsibilities

  • Prepare APR reports and sub-reports to show product performance, validation status, and determine compliance
  • Coordinate with other departments to complete APR sub-reports
  • Communicate and provide APR related information to Regulatory Affairs and external customers
  • Process, review, and approve change controls in Trackwise
  • Write and/or review/approve investigations, cGMP documents, processes, etc.
  • Review and approve documents in Trackwise
  • Compile and maintain metrics and tracking logs at the request of management and hit metrics delivery schedules
  • Review and approve protocols, batch record revisions, raw data, and reports
  • Participate in ongoing and new quality, compliance and process initiatives at the site
  • 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 and procedures, cGMPs, SOPs, and Batch Record instructions
  • Perform other duties as assigned

 

Qualifications

  • Bachelor's degree or equivalent education/experience
  • Minimum of 3 years experience in a manufacturing environment within a pharmaceutical, medical device, nutraceutical, or food processing industries preferred
  • Experience and knowledge of cGMP and other applicable industry regulatory requirements as they relate to production of pharmaceutical products and associate quality systems
  • Experience with handling of change controls, investigations, and CAPAs required
  • Experience with Trackwise, LIMS/Labware, Crystal Reports, Learning Management Systems and statistical software preferred
  • Experience in a solid dose manufacturing environment preferred
  • ASQ Certification preferred

 

Working Environment

  • Occasional exposure to moderate to loud noise levels
  • Occasional exposure to moving mechanical parts or equipment
  • Occasional exposure to fumes, odors, dusts, mists, gasses, or vibrations
  • May be required to wear personal protective equipment as needed in production areas

 

 

Teva Pharmaceuticals USA requires all U.S. new hires to be fully vaccinated for COVID-19 prior to the first date of employment. As required by applicable law, however, Teva will consider requests for reasonable accommodations.

Function

Quality

Sub Function

Manufacturing Quality Assurance

Reports To

Manager, Quality Assurance

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.

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.

 

Inclusion & Diversity at Teva

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.


Nearest Major Market: Fort Lauderdale
Nearest Secondary Market: Miami