1+ months

Quality Specialist II

West Chester, PA 19380
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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 West Chester, PA production site is one of our solid 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!

 

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

 

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

Responsibilities include, but are not limited to:

  • Review of Technical Transfer Reports (TTR) for transfer of manufacturing processes from Process Development to the Biologics Manufacturing Facility
  • Providing Quality Assurance oversight of technology transfer plans and reports, and process validation documentation
  • Review and approval of master batch records to ensure alignment with the TTR
  • Review and approval of executed batch records for compliance to the master batch record and TTR
  • Review and approval of analytical test results and Certificates of Analysis (CoAs) to support product disposition
  • Review and approval of deviations, CAPAs, OOS/OOT investigations and change controls
  • Product Disposition decisions for cell banks, bulk drug substances and drug products
  • Writing/revising, review and approval of site SOPs, Work Instructions and Forms
  • Support site efforts to ensure compliance with Teva Policies and Standards, and regulatory requirements and GMP guidelines
  • Support the site vendor management activities, as requested.
  • Provides support for internal audits

Qualifications

  • BS (or higher) degree in life science or chemistry.
  • Minimum 5 years of experience in pharmaceutical or biotech quality assurance
  • Strong knowledge of GMP regulations and quality compliance (cGMP, ICH guidelines, FDA/EMA/MHRA regulations, USP/EP)
  • Experienced  reviewer of QC  analytical data is a plus
  • Excellent oral and written communication skills
  • Ability to work with minimal supervision
  • Critical thinking and multi-tasking skills are a must
  • Detail oriented with strong organizational skills
  • Team player, able to work collaboratively with all levels of QA, Manufacturing, and Quality Control staff.

Function

Quality

Sub Function

R&D Quality

Reports To

Quality Assurance Director, Quality Site Head, R&D QA

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 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. 

Posted: 2021-01-12 Expires: 2021-05-22

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 Specialist II

Teva Pharmaceuticals
West Chester, PA 19380

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