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Microbiology Supervisor

Date: Oct 13, 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

 

Responsible for coordinating laboratory personnel and all activities associated with the functional area to ensure that the laboratory operates efficiently and effectively while performing routine and non-routine tasks.
Oversee a team responsible for data generation and review in support of batch releases. 


• Generate product testing schedule and coordinate sample receipt from Manufacturing, Stability, and Validations and delivery to the appropriate QC Microbiology Product Testing laboratories.
• Responsible microbiological culture media and reagent receipt, quarantine, testing and release to support laboratory operations.
• Provide technical knowledge, training, and guidance to lab associates for product testing, critical utilities sampling and testing, equipment qualifications, and laboratory control to ensure all processes meet company and regulatory requirements.
• Responsible for staffing, training and development of subordinates, and the control of financial resources to maintain and improve product quality consistent with department and company operating objectives.
• Review raw data and enter, verify and/or release results with a Laboratory Information Management Systems (LIMS).
• Conduct and document investigations for OOS results, environmental excursions and other laboratory discrepancies as required.
• Directs the investigation of microbiology related in-process, finished product and environmental systems excursions.
• Interact with other departments and area owners to ensure effective and efficient communication of critical information.
• Interface with FDA and other regulatory agencies during Prior Approval (PAI), routine or field complaint inspections
• Implement process validation programs to establish and maintain a satisfactory level of compliance with regulatory requirements.
• Provides technical support to R&D, Validations, and Engineering.
• Writes and/or reviews environmental data trending reports for clean rooms on a routine and timely basis.
• Writes, revises and approves microbiology department procedures.
 

Qualifications

 

• BS degree in Microbiology or closely related field.
• 1 years of previous supervisory experience.
• 6 years of laboratory experience associated with the QC Microbiology testing performed in a pharmaceutical company.
• 6 years Experience with Kinetic Chromogenic Lysate and/or Kinetic Turbidimetric bacterial endotoxin test required
• 6 years Experience with Steritest® sterility test apparatus and methods required
• 6 years Experience with Laboratory Information Management Systems required.
• Experience in Terminal Sterilization and Aseptic Manufacturing
• Experience in Equipment and Test Method Validation
• Knowledge of scientific theories, instrumentation and techniques 
• Experience with both Microscopic and Light Obscuration Particle Count Tests (HIAC or equivalent) preferred.
• Knowledge of cGMPs, EP and USP requirements and microbiological test methods.
• Knowledge and experience in aseptic processing environments preferred.
• Experience with Isolator Technology used for sterility testing and/or drug product manufacture preferred.

Function

Quality

Sub Function

Manufacturing Quality Assurance

Reports To

In process of validation

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