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Sr. Sterility Assurance Specialist, Microbiology

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

 

The Sr. Sterility Assurance Specialist, Microbiology will provide technical expertise and guidance for all activities associated with Microbiology, Sterilization and Aseptic programs to support Manufacturing, Environmental Monitoring, and site projects. Position will serve as microbiology and sterilization subject matter expert for projects and engage collaboratively with cross-functional areas including production, MS&T, sterilization, facilities, engineering, internal laboratories and external contract research and testing facilities. 


Responsibilities: Essential Duties
• Provide microbiological and sterilization expertise to quality, manufacturing, technical services, engineering and MS&T throughout all phases of project including routine manufacturing, innovation, development and technology transfer.
• Provide microbiological and sterilization expertise to quality, manufacturing, technical services and engineering for continuous improvement initiatives.
• Provide microbiological and sterilization expertise to quality to sustain and enhance (as needed) the site contamination control strategy.
• Author and review/approve assessments, procedures, technical reports and other sources of information to ensure that microbiology sampling and testing methods are consistent with compendial guidance, current industry practices and regulatory requirements.
• Technical expert and responsible for implementing microbiology and sterilization validation programs for new and current products
• Author and review non-conformance investigations related to Environmental Monitoring or Microbiological Testing of raw material/component, in-process or finished goods.
• Prepares trend analysis and data compilation on deviations 
Expertise: Knowledge & Skills
• A strong scientific knowledge in areas pertaining sterilization approaches and processes
• Knowledge of environmental, utility and facility monitoring programs, including area classifications and process analytical technology applications.  Familiarity with equipment installation and qualification and electronic data systems.  
 

Qualifications

 

• Degree in Microbiology, Molecular Biology, Biochemistry, or a related science with significant microbiology coursework.
• Master’s degree is highly preferred.
• 8 years Pharmaceutical industry experience in a cGMP environment.
• Strong technical expertise in areas related to: sterility testing, bioburden, endotoxin levels, sub-visible liquid particulate matter analysis, biological indicators (manufacturing, testing & use), and cleanroom contamination, environmental monitoring, gowning, cleaning/disinfection, sampling methods and sampling plans.
• Demonstrated industry experience in several of the following areas: microbiological method development and validation, D & z value determination, container-closure integrity testing (CCI), microbial ingress, process hold time studies, aseptic process simulations, WFI generation system validation and routine monitoring requirements, equipment cleaning validation, vaporized hydrogen peroxide and other surface decontamination validation approaches.
• Experience with aseptic manufacturing of small and large volume parenterals is preferred.
• Experience with Restricted-Air Barrier Systems, and Isolator Technology.

 

 

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