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Sr Quality Analyst

Date: Nov 25, 2022

Location: West Chester, Pennsylvania, US, 19380

Company: Teva Pharmaceuticals

Company Info

Together, we’re on a mission to make good health more affordable and accessible, to help millions around the world enjoy healthier lives. It’s a mission that bonds our people across nearly 60 countries and a rich, diverse variety of nationalities and backgrounds.

Working here means working with the world’s leading manufacturer of generic medicines, and the proud producer of many of the products on the World Health Organization’s Essential Medicines List. Today, at least 200 million people around the world take one of our medicines every single day. An amazing number, but we’re always looking for new ways to continue making a difference, and new people to make a difference with.

 

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. 

 

This position is eligible for relocation and will work a hybrid schedule of 3 days in-office. 

 

 

Job Description

The Senior Quality Analyst works with local and global R&D product development teams to ensure compliance to the Quality Management System (QMS) for combination products delivery from concept through industrialization and commercial life cycle management. This includes but is not limited to: project design specifications, drawings, plans/protocols/reports related to design verification/validation, method validation, risk management activities, change controls, etc. The role assures that project output meets combination product regulatory requirements. This position assists in the development and implementation of site/global QMS GMP policies and procedures. Additional responsibilities will ensure departmental compliance in generating and maintaining design control files (DHF’s, DMR’s).

 

 

Essential Duties & Responsibilities

  • Provide quality compliance support for local/satellite R&D teams as required.  Review and approve device design project documentation in partnership with internal business partners and external business partners (product design specifications, drawings, plans/protocols/reports related to design verification/validation, method validation, change controls, non-conformances and other applicable documentation) to confirm that the output meets 21 CFR Part 4 combination product regulatory requirements
  • Actively participates in the maintenance of the Global R &D Quality Management System (QMS) in support of design control development of drug delivery devices
  • Identify, recommend, communicate, and follow-up compliance and surveillance with R&D laboratory business partners with deviations, CAPAs, change controls
  • Work with R&D staff and business partners in solving complex quality issues affecting laboratory operations and device components/assembly
  • Provide quality support for design and/or technical transfer including support in drafting, review, execution, and approval of protocols and reports
  • Manage and assure necessary project development contact and Quality support is maintained with business partners and Teva site teams
  • Represent R&D Quality in design decisions
  • Perform internal/external audits
  • Communicate with management on device development status

Qualifications

  • Bachelor's Degree in an appropriate scientific or engineering discipline required
  • Minimum 3 years experience in medical devices, combination products or pharmaceutical GMP required
  • Thorough understanding of quality management systems required
  • Knowledge of FDA 21 CFR820, ISO 13485, 21CFR 210/211, TrackWise, general EDMS and supplier relationship management a plus
  • Internal/external auditing experience required
  • Mechanical testing/automated equipment experience preferred
  • Injection molding/manufacturing experience preferred
  • ISO13485 auditing experience preferred

 

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

R&D Quality

Reports To

Associate Director, R&D Quality- Combination Product and Device

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: Philadelphia