Katalyst CRO
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Microbiologist II
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Microbiologist II
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Katalyst CRO Get AI-powered advice on this job and more exclusive features. Overview
We are seeking a skilled and detail-oriented Senior QC Microbiologist to support Quality Control operations through microbiological testing, environmental monitoring, and method validation. This role involves executing lab protocols in compliance with USP, cGMP, and regulatory standards. The ideal candidate will support and lead microbiology-related project work, act as a subject matter expert (SME) during audits, and contribute to method development and technology transfer efforts. Overview
We are seeking a skilled and detail-oriented Senior QC Microbiologist to support Quality Control operations through microbiological testing, environmental monitoring, and method validation. This role involves executing lab protocols in compliance with USP, cGMP, and regulatory standards. The ideal candidate will support and lead microbiology-related project work, act as a subject matter expert (SME) during audits, and contribute to method development and technology transfer efforts.
Responsibilities
Perform microbiological and microbial limits testing of raw materials, in-process samples, finished products, and stability samples per USP and regulatory standards. Conduct routine environmental monitoring and water sampling/testing. Execute microbiology sampling techniques and test methods accurately. Troubleshoot microbiological issues, support investigations, and implement effective CAPA. Manage and support change controls related to microbiology procedures and systems. Serve as microbiology SME during internal, customer, and regulatory audits. Author, review, and revise SOPs, protocols, and test methods for microbiology. Lead or contribute to validation of test methods and qualification of lab equipment. Coordinate third-party lab testing and ensure timely and accurate data reporting. Ensure microbiological control of the environment, equipment, and facilities. Maintain laboratory equipment, media inventory, and accurate testing documentation. Support cross-functional teams in method transfers and project execution. Ensure compliance with all Safety, Health, and Environmental (SHE) protocols. Take immediate corrective actions for any unsafe practices or compliance risks.
Requirements
Bachelor's degree in Microbiology, Biology, or a related scientific field (Master's preferred). Minimum of 3 years of experience in a QC microbiology or pharmaceutical lab environment. Strong knowledge of USP, cGMP, and regulatory microbiological requirements. Experience in method development, validation, and equipment qualification. Familiarity with environmental monitoring programs and aseptic techniques. Excellent documentation, organizational, and communication skills. Experience supporting audits and working within cross-functional teams.
Seniority level
Seniority level Entry level Employment type
Employment type Contract Job function
Job function Research, Analyst, and Information Technology Industries Pharmaceutical Manufacturing Referrals increase your chances of interviewing at Katalyst CRO by 2x Sign in to set job alerts for “Microbiologist” roles.
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Microbiologist II
role at
Katalyst CRO 2 days ago Be among the first 25 applicants Join to apply for the
Microbiologist II
role at
Katalyst CRO Get AI-powered advice on this job and more exclusive features. Overview
We are seeking a skilled and detail-oriented Senior QC Microbiologist to support Quality Control operations through microbiological testing, environmental monitoring, and method validation. This role involves executing lab protocols in compliance with USP, cGMP, and regulatory standards. The ideal candidate will support and lead microbiology-related project work, act as a subject matter expert (SME) during audits, and contribute to method development and technology transfer efforts. Overview
We are seeking a skilled and detail-oriented Senior QC Microbiologist to support Quality Control operations through microbiological testing, environmental monitoring, and method validation. This role involves executing lab protocols in compliance with USP, cGMP, and regulatory standards. The ideal candidate will support and lead microbiology-related project work, act as a subject matter expert (SME) during audits, and contribute to method development and technology transfer efforts.
Responsibilities
Perform microbiological and microbial limits testing of raw materials, in-process samples, finished products, and stability samples per USP and regulatory standards. Conduct routine environmental monitoring and water sampling/testing. Execute microbiology sampling techniques and test methods accurately. Troubleshoot microbiological issues, support investigations, and implement effective CAPA. Manage and support change controls related to microbiology procedures and systems. Serve as microbiology SME during internal, customer, and regulatory audits. Author, review, and revise SOPs, protocols, and test methods for microbiology. Lead or contribute to validation of test methods and qualification of lab equipment. Coordinate third-party lab testing and ensure timely and accurate data reporting. Ensure microbiological control of the environment, equipment, and facilities. Maintain laboratory equipment, media inventory, and accurate testing documentation. Support cross-functional teams in method transfers and project execution. Ensure compliance with all Safety, Health, and Environmental (SHE) protocols. Take immediate corrective actions for any unsafe practices or compliance risks.
Requirements
Bachelor's degree in Microbiology, Biology, or a related scientific field (Master's preferred). Minimum of 3 years of experience in a QC microbiology or pharmaceutical lab environment. Strong knowledge of USP, cGMP, and regulatory microbiological requirements. Experience in method development, validation, and equipment qualification. Familiarity with environmental monitoring programs and aseptic techniques. Excellent documentation, organizational, and communication skills. Experience supporting audits and working within cross-functional teams.
Seniority level
Seniority level Entry level Employment type
Employment type Contract Job function
Job function Research, Analyst, and Information Technology Industries Pharmaceutical Manufacturing Referrals increase your chances of interviewing at Katalyst CRO by 2x Sign in to set job alerts for “Microbiologist” roles.
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We’re unlocking community knowledge in a new way. Experts add insights directly into each article, started with the help of AI.
#J-18808-Ljbffr