1+ months

Senior Quality Engineer

Irvine, CA 92606
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 Irvine, CA production site is one of our complex 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 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

Teva is searching for a Senior Quality Analyst to join our Quality Engineering team in Irvine, CA!

The Senior Quality Analyst will be a senior quality representative on a team responsible for quality oversight of a commercial aseptic manufacturing and packaging facility.

This role supports the quality engineering team in an individual contributor capacity focusing on:  independent review and QA approval of maintenance work orders, manufacturing and laboratory equipment/instrument commissioning/qualifications, facilities, critical utilities (WFI, CCA, HVAC, CSM, etc.), computer systems, media fills, and process/product validations, and continuous improvement projects. 

 

You will:

  • Work in collaboration with other key operational departments to resolve complex quality and operational issues.
  • Provide effective and timely decision-making, project management, and teamwork skills utilizing risk-based approaches, especially with real-time unplanned maintenance work order approvals, emergency change controls, and project support.
  • Collaborate with Engineering and Production especially in execution of risk assessments, and support the area Quality manager responsible for quality oversight of re-commissioning of the plant facilities and critical utilities after facility shutdown.
  • Lead various projects including continuous improvement activities, and leverage lean/OPEX principles to ensure robust and efficient compliant systems and processes.
  • Review and approve independently the following GMP documents: facility and maintenance work orders, controlled logbooks supporting facilities,  pest control reports, validation periodic review protocols and reports, Standard Operating Procedures (SOPs), change control documents, minor and major deviation investigations, engineering drawings, and HEPA recertification reports.   
  • Support the Aseptic Process Simulation program at Teva Irvine ensuring all requirements are met and product/APS matrix is current.
  • Execute and improve assigned key performance work metrics using trend charts and/or statistical analysis in support of continuous improvement and Annual Product Reviews and department metrics.
  • Actively support inspections/audits of Teva Irvine by Regulatory agencies/internal auditors.
Qualifications
  • Bachelors degree in related Science, Life Science or Engineering field required.  Masters degree is preferred. Additional relevant certifications preferred (ASQ and similar).
  • Minimum 6 years experience in the pharmaceutical or Biopharma industry required.
  • 2 years in an aseptic/sterile manufacturing facility required. 4 years preferred.
  • 3+ years working with Equipment Qualification and Process Validation in a commercial GMP operation preferred.
  • 3 years experience using contemporary approach to Commissioning and Qualification preferred.
  • Validation using risk-based approach leveraging Critical Process Parameters and Critical Qualification Attributes preferred.
  • 2+ years working directly within a Quality Assurance role supporting review and approval of technical documents in a commercial operation preferred.
  • Experience actively interacting with FDA or other regulatory bodies in GMP/PAI inspections as an area SME, host, escort or scribe strongly preferred.
  • Experience in auditing techniques in a cGMP aseptic/sterile facility with the ability to gown for clean room environment.
  • Working knowledge in Root Cause Analysis (5 Whys, 6Ms, Is/Is Not, FMEA, etc.) in support of deviation/CAPA investigations to determine adequate and effective CAPAs.
  • Working knowledge of GAMP 5 and Parenteral Drug Association (PDA) requirements.
  • Working knowledge of Lean/5s, and/or DMAIC tools.
  • Demonstrated effective teamwork experience and ability to indirect develop lower level quality personnel and provide leadership to internal/external customers including providing internal technical training. 
  • Ability to provide effective prioritization and project management skills to manage the day to day along with longer-term projects/tasks while ensuring the facility is compliant.
  • Ability to interpret current Good Manufacturing Practices (cGMP), Food and Drug Administration (FDA), and other regulatory requirements applicable to operations supporting aseptic/sterile manufacturing and packaging functions.
  • Experience with risk-based decision making on a strategic level affecting multiple systems, facilities, batches, etc. 
Function
Quality
Sub Function
Manufacturing Quality Assurance
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.

Categories

Posted: 2020-08-14 Expires: 2020-11-04

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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Senior Quality Engineer

Teva Pharmaceuticals
Irvine, CA 92606

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