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Quality Analyst II

Date: Jan 12, 2021

Location: West Chester, Pennsylvania, US, 19380

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!

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 to support product disposition
  • Review and approval of deviations, OOS/OOT investigations, change controls and the Certificate of Analysis
  • 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.

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’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.


Nearest Major Market: Philadelphia