1+ months

Quality Analyst II

Davie, FL 33314
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Company Info

If youre like people at Teva, you dare to be different. Were 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.

Tevas Davie and Sunrise (Florida) production sites are two of our largest launch facilities.   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 worlds 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 worlds largest medicine cabinet to 200 million people every day. We offer a uniquely diverse portfolio of products and solutions for patients and we have 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

This position is primarily responsible for the review of batch record files and final product release for shipment to end customer and to participate in investigations and trending of quality issues as appropriate.  Additionally, this position will support QA in-line inspections for all manufactured batches and issue/review/release raw materials, labeling materials and packaging materials as needed.

 

  • Responsible for conducting review and release activities associated with product and material release with minimal oversight directed at anomalous issues or observations.
  • Responsible for performing activities in support of QA Operational support which may include label issuance, floor support, audit/walkthrough support, AQL assessment, investigation assessment, and training; and other QA groups as needed.
  • Responsible for compiling and maintaining metrics and tracking logs at the request of management and successfully hitting metrics delivery schedules.
  • Responsible for writing and/or reviewing/approving investigations, cGMP documents, processes, etc. in a thorough and timely manner.
  • Responsible for leading ongoing and new quality, compliance and process initiatives at the site (i.e. reducing events related to human errors). 
  • Responsible for serving as QA lead on research and development products and related document reviews/approvals including change control items, protocols, batch records and deviations as applicable and product disposition.
  • Responsible for providing support, training and guidance to others within QA (i.e. Quality Engineering and Document Control) and other departments as needed.
  • Responsible for providing first response and ongoing QA presence for quality and compliance issues on the manufacturing floor and as needed in the laboratories.
  • Responsible for completing all training requirements and maintaining 100% compliance with all assignments.  

Qualifications

Education/Certification/Experience:

  • Requires a Bachelors degree or equivalent education/experience with a minimum of three to five years relevant QA experience in a manufacturing environment within pharmaceutical, medical device, nutraceutical, or food processing industries preferred.
  • 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.
  • Requires experience with the handling of deviations, investigations and CAPAs.
  • Experience with Manufacturing/Quality systems such as Trackwise, LIMS/Labware, Crystal Reports, Learning Management Systems and statistical software preferred.
  • Experience in a solid dose manufacturing environment preferred.
  • ASQ Certification preferred.

Function

Quality

Sub Function

Manufacturing Quality Assurance

Reports To

In process of validation

Tevas 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.

Posted: 2019-05-17 Expires: 2019-08-17

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 Analyst II

Teva Pharmaceuticals
Davie, FL 33314

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