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Senior QA Associate - Aseptic

Date: Nov 17, 2021

Location: Irvine, California, US, 92618

Company: Teva Pharmaceuticals

Company Info

If you’re like people at Teva, you dare to be different. We’re 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.

 

Teva’s 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!

Relocation Offered.

Job Description

Quality Analyst- Aseptic professional at an aseptic, sterile vial fill and finish manufacturing and packaging facility responsible for quality review and approval of protocols, reports, and change controls regarding Aseptic process , Media fill ,training and qualification for clean room   . Will support Quality Assurance activities such as authoring deviation investigation and change controls as needed related to EM , Media fill , process and etc .

 

The incumbent will be a key team member of the QA team responsible for QA oversight of process/product validation, production and packaging -related investigations and change controls in support of both existing products and new product launches. Under limited guidance, analyzes and resolves quality issues in an aseptic/sterile cGMP commercial manufacturing facility and drives to resolve complex work process issues through project management/execution, problem solving, risk analyses (FMEAs), and designing/implementing process improvement solutions. Develops plans and complex strategies for implementation of corrective and preventive measures that are efficient and robust.


 Executes and interprets key metrics and trend charts using data and/or statistical analysis in support of Annual Product Review and Quality Metrics. Drives quality risk assessment as well as effectiveness checks as part of Change Control and CAPA processes. Demonstrates effective leadership and teamwork to junior and senior level Quality personnel. Complies with all company policies and procedures, including safety rules and regulations, current Good Manufacturing Practices (cGMP), Food and Drug Administration (FDA), and other regulatory requirements applicable to aseptic/sterile manufacturing and packaging operations. Performs other related duties as assigned.

Qualifications

•Bachelor’s degree in Science or related field from an accredited college or university and at least 4 years of quality engineering or related QA experience in a cGMP manufacturing environment with at least 8  years in an aseptic/sterile environment.
•Experience in Current Good Manufacturing Practices (cGMP), Food and Drug Administration (FDA), and other regulatory requirements applicable to aseptic/sterile manufacturing and packaging environment
•Experience in Validation and Qualification – process, product, equipment, and EM
•Experience of Root Cause Analysis (5 Whys, 6M’s, Is/Is Not, FMEA, etc) in support of writing, reviewing, and approving investigations to determine root cause and adequate corrective/preventive actions to prevent recurrence.
•Experience in Auditing techniques in a cGMP aseptic/sterile facility.
•Experience and mastery in technical writing for investigations, protocols, and reports in English language.
•Knowledge in Applied statistics and trend analysis such as SPC, Capability Analysis, and regression analysis.
•Knowledge of Lean/5s application

•Need experience in TrackWise and electronic maintenance programs.

•Plus is experience with EAMS maintenance program and Oracle ERP system.

Function

Quality

Sub Function

Quality Assurance Methods

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.

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: Irvine California
Nearest Secondary Market: Los Angeles