1+ months

Quality Analyst II

West Chester, PA 19380

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

    Support the Vendor/Supplier Management Program. 

  1. Handle requests for new vendors and initiate the evaluation/qualification process, including review and assessment of vendor remote audit questionnaires
  2. Issue, and track to completion vendor complaints 
  3. Ensure Supplier Change Notifications are reviewed and addressed by the proper site functions
  4. Participate in routine vendor monitoring and requalification
  5. Generation and management of quality agreements and assist Tevas Global Regulatory Audits in preparation for vendor audits

    Raw material disposition and release. 
    Support area room clearances and product changeover activities.
    Review and approval of environmental and utilities monitoring data 
    Review and approval of procedures and changes related to process and utilities automation systems
    Participate in the QA On-The-Floor Program in the production facility. This includes quality support of manufacturing activities in Upstream, Downstream, Fill/Finish, and Cell Banking. 
    Strong understanding of gowning and aseptic techniques for controlled environments.
    Review and approve production batch records, validation protocols/reports, method transfer protocols/reports, and Controlled Material Specifications.
    Utilize Quality Systems to review and approve change controls, deviations, laboratory investigations, CAPAs and CAPA Effectiveness checks.
    Review and approval of SOPs, work instructions and controlled forms.
    Support GMP compliance and inspection readiness within the organization. Participate in internal audits and inspections.
    Support regulatory agency filings, inspections and partner/Teva Audits as required.
    Ensure alignment with corporate standards and cGMP guidelines.  As requested, perform or facilitate gap assessments, comparing site SOPs against Corporate Standards
    Utilizing established QA procedures and methodologies, exercise judgment to propose solutions for straight forward problems under limited guidance/coaching. Escalate critical to quality issues to management in a timely manner.
    Support cross functional department customers in a manner which is clear in approach, communication and action. Provide proactive communication to customers to ensure timely escalation and resolution of issues. Follow up on issues to ensure completion in a timely manner. Support cross functional communication in all matters.
    Champion a culture of continuous improvement and industrial excellence.

Qualifications

    BS or MS degree in life sciences.  Minimum of 3 years experience in pharmaceutical / biotech Operations or Quality Assurance
    Knowledge in quality compliance (cGMP/ICH/FDA/USP/EP policies/guidelines) required.
    Excellent oral and written communication, critical thinking and multi-tasking skills.
    Cooperative, independent, detail oriented and strong organizational skills.
    Familiarity with biopharmaceutical operations, experience with documentation management, training management, and audit experience.
    Experience with pharmaceutical process and utilities automation systems.

Function

Quality

Sub Function

R&D Quality

Reports To

Mgr Quality Assurance, 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. 

Categories

Posted: 2021-02-26 Expires: 2021-04-28

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
West Chester, PA 19380

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