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Microbiology Expert
2 months ago
Job Summary:
We are seeking a highly skilled Microbiology Expert to join our team at the Novartis Group Companies. As a key member of our Quality Control department, you will be responsible for performing microbiological testing and other activities to ensure the quality and safety of our products.
Key Responsibilities:
- Perform microbiological testing and other activities in support of clinical release strategies.
- Ensure all testing and activities are compliant with appropriate SOPs and procedures.
- Maintain controls and reference standards to support testing.
- Execute and follow SOPs, WPs, and quality policies and peer review and archive analytical data in lab documentation systems.
- Support monthly/quarterly laboratory cleaning and ensure cleanliness of laboratory working areas.
- Manage reagent/consumable inventory and equipment cleaning for assigned areas of responsibilities.
- Ensure all assigned training is completed within required time frame.
- Support 5S and Lean projects, identify process improvements.
- Interface with regulatory agencies during audits as required.
- Provide coverage for all appropriate areas and contribute to assigned projects by following predefined tasks and executing as instructed.
Requirements:
- Bachelor's degree in biology, chemistry, biochemistry, microbiology or other related area. MS is preferred.
- At least 1 year of relevant experience in the pharmaceutical, biologics, microbiology, sterile manufacture, medical device industry or related industry.
- Thorough knowledge of microbiological and environmental monitoring, test methods is required.
- Ability to communicate clearly with a variety of individuals in various aspects of Novartis operations.
- Detail-oriented with expertise in problem solving and solid decision-making abilities.
- Strong interpersonal skills which include a professional demeanor when interacting with Novartis personnel.
- Strong written and verbal communication skills are essential.
Preferred Requirements:
- Knowledge of cGMP and an understanding of the concepts of GLP, good clinical practices and FDA guidelines, applicable state and foreign regulations, and standards routinely used in the industry (i.e., ANSI, ISO, etc.)
- Micro/Environmental knowledge to facilitate investigations is preferred
- Knowledge of LIMS systems is preferred
About Novartis:
The Novartis Group of Companies is a global leader in the pharmaceutical and biotechnology industries. We are committed to improving the lives of patients and communities around the world through innovative science and bold innovation.
Benefits and Rewards:
We offer a comprehensive benefits package and competitive compensation to our employees. We are committed to building diverse teams and creating an inclusive workplace that cultivates bold innovation through collaboration and empowers our people to unleash their full potential.
