Microbiologist II - QC Team

Job Description

Job Description

We are seeking a Microbiologist II to join our Quality Control (QC)team and support the microbiological analysis of products, stability samples, validation samples, raw materials, and environmental samples. This role is vital in ensuring product quality through testing, method validation, and participation in continuous improvement initiatives.

Job duties:

 

Microbiological Testing and Monitoring

• Conduct microbiological monitoring for:
• • Purified water systems, laboratory water systems, and compressed air systems.
  • Active air monitoring and environmental sample collection (including equipment monitoring).
• Perform USP <60> , USP <61> , and USP <62> testing to detect and quantify microbial contaminants in pharmaceutical products and raw materials.
• Conduct USP <51> testing for antimicrobial effectiveness studies.

Data Analysis and Regulatory Compliance

• Analyze and interpret microbiological data, ensuring compliance with regulatory standards and company Standard Operating Procedures (SOPs).
• Maintain detailed and accurate documentation in accordance with regulatory and quality standards.

Subject Matter Expertise and Improvement Efforts

• Act as a Subject Matter Expert (SME) for core functional areas of microbiology.
• Support method validation activities and participate in continuous improvement projects to enhance quality control processes.

Required qualifications:

• Bachelor of Science in Microbiology or a related scientific field
• One or more (1+) years of experience working in a microbiology lab
• Strong written and verbal communication skills, excellent documentation, and organizational skills
• Demonstrated critical thinking and problem-solving skills
• Willingness to take ownership of assigned tasks and responsibility for the results
• Ability to work independently and as part of a collaborative team

Preferred qualifications:

• Experience in a pharmaceutical or similar industrial setting
• Hands-on experience with, and knowledge of, aseptic techniques
• Familiarity with USP <60> , <61> , <62> , and <51> testing methodologies

Company Description

Our focus is on health care products that improve people’s lives. We are a market-leading generic prescription pharmaceutical company that specializes in “extended topical” medications, like creams, foams, mousses, gels, liquids and inhalable products.

It’s a great time to join our team because we have a high growth trajectory with now more than 1,300 employees across six locations in the United States and Israel. We’ve already established a successful track record of launching first-to-file and first-to-market generic pharmaceutical products that have helped to make prescription products more affordable for patients and reduce costs for the healthcare system.

Company Description

Our focus is on health care products that improve people’s lives. We are a market-leading generic prescription pharmaceutical company that specializes in “extended topical” medications, like creams, foams, mousses, gels, liquids and inhalable products.\n\nIt’s a great time to join our team because we have a high growth trajectory with now more than 1,300 employees across six locations in the United States and Israel. We’ve already established a successful track record of launching first-to-file and first-to-market generic pharmaceutical products that have helped to make prescription products more affordable for patients and reduce costs for the healthcare system.