What are the responsibilities and job description for the Senior Microbiologist position at Teva Pharmaceuticals?
Who we are
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!
The opportunity
POSITION SUMMARY
This position is responsible for providing reliable and expedient results from the testing and analysis of incoming materials, intermediates, finished products, swab samples, and other samples to support the commercial and development activities in compliance with all regulatory requirements, company policies and procedures. Additionally, this position will provide training and / or direction to junior analysts and function as a subject matter expert for all aspects of Quality Control Laboratory microbiology testing in compliance with cGMP and SOPs.
ESSENTIAL AREAS OF RESPONSIBILITY
All areas of responsibility listed below are essential to the satisfactory performance of this position by any incumbents with reasonable accommodation, if necessary. Any non-essential functions are assumed to be included in other related duties or assignments.
- Responsible for scheduling and tracking analysis of incoming materials, intermediates, finished products, swab samples, water samples, environmental monitoring samples, and other samples as needed.
- Responsible for preparing, maintaining, and reviewing thorough records.
- Responsible for conducting investigations and root cause analysis for microbiology related deviations. Support and / or lead laboratory investigations into Out of Specification / Out of Trend results or other laboratory events.
- Responsible for authoring and reviewing microbiological test protocols, technical reports, risk assessments, and validation documents.
- Responsible for performing complex revisions to documentation (including the use of Change Control) such as Standard Operating Procedures, Test Methods, and Specifications.
- Responsible for performing method suitability for compendial methods.
- Responsible for designing and overseeing the execution of complex projects such as method transfers, validations, and regulatory reports.
- Responsible for performing activities associated with the stability program including sampling and statistical analyses.
- Responsible for executing projects of an advanced scope and complexity as assigned.
- Responsible for preparing and providing training to small or large groups and leading meetings as needed.
- Responsible for communicating with multiple departments including manufacturing, planning, and regulatory affairs.
- Responsible for completing all training requirements and maintaining 100% compliance with all assignments.
- Responsible for maintaining work areas and performing job functions in a safe and efficient manner in accordance with company policies and procedures, Good Manufacturing Practices (cGMP's), Standard Operating Procedures (SOP's) and Batch Record instructions.
- Responsible for performing additional related duties as assigned.
Your experience and qualifications
Education / Certification / Experience :
Skills / Knowledge / Abilities :
Problem Solving :
Visual Acuity :
WORKING ENVIRONMENT
Enjoy a more rewarding choice
We offer a competitive benefits package, including :
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 policy that equal employment opportunity be provided without regard to age, race, creed, color, religion, sex, disability, pregnancy, medical condition, genetic information, marital status, sexual orientation, gender identity or expression, ancestry, national or ethnic origin, citizenship status, military status or status as a disabled or protected veteran, or any legally recognized status entitled to protection under applicable federal, state, or local laws.
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. Request a reasonable accommodation by sending an email to disabilityassistance@tevapharm.com with the nature of your request and your contact information. Only inquiries concerning a request for a reasonable accommodation will be responded to from this email address.
Important notice to Employment Agencies - Please Read Carefully
Teva Pharmaceuticals USA does not accept unsolicited assistance from agencies for employment opportunities. All CVs / resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company. No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails.
