Katalyst CRO ยท 1 day ago
Microbiologist II
Tampa, FL
Contract
Onsite
Mid Level
3+ years expKatalyst CRO is a contract research organization specializing in laboratory testing. They are seeking a Microbiologist II to carry out laboratory work including method development, validation, and quality control testing of raw materials and finished products.
AnalyticsBiopharmaData ManagementHuman ResourcesQuality Assurance
Responsibilities
Performs, analyzes, and interprets QC and microbial limits testing according to USP and regulatory requirements for raw materials, finished products, and stability samples
Perform environmental monitoring which includes water sampling and testing
Performs microbiology methods and sampling techniques
Performs investigations and completes CAPA in response to laboratory investigations
Manages change controls effectively
Manages/ supports microbiology projects from production or formulations development dept
Actively participates in customer and regulatory audits as area SME
Develops and executes validation protocols for test methods and equipment qualification
Author and review SOPs and test methods related to microbiology
Ensure the microbiological integrity of environment, equipment and facilities
Manages product testing based upon internal and customer specifications
Managing 3rd party laboratory testing and reporting of data and EM when necessary
Report on testing results, including CoA's
Maintain equipment, media, and sample logs as needed
Ensure the micro lab is adequately supplied and maintained
Perform other responsibilities to support the business as requested
Adhere to all defined Safety and Sustainability requirements and expectations and seek clarification whenever Safety and Sustainability requirements and expectations are either unknown or unclear
Promptly report identified Safety and Sustainability issues, problems, deficiencies, errors, incidents, and/or opportunities to management and correct where possible
Stop work where deemed necessary to maintain safety
Qualification
Required
3+ years of lab experience in QC or microbiology
Associate's degree or higher in a science-related field
Knowledge of USP and regulatory testing standards
Good communication and teamwork skills
Company
Katalyst CRO
Katalyst CRO | Advancing Healthcare & Life Sciences with Expert Research & Regulatory Solutions Katalyst Healthcare & Life Sciences (Katalyst CRO) is a Global Contract Research and Knowledge Process Outsourcing Organization (CRO) dedicated to driving innovation in research, regulatory compliance, and quality excellence for pharmaceutical, biotechnology, and medical device companies worldwide.
51-200 employees
H1B Sponsorship
Katalyst CRO has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (28)
2024 (14)
2023 (24)
2022 (52)
2021 (54)
2020 (39)
Funding
Current Stage
Growth StageLeadership Team
John Patil
Recruiter, Pharma/CRO Staffing Division
Recent News
2024-04-07
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