Microbiologist

Zeus-posted 18 days ago

Full-time • Mid Level

Columbia, SC

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The Company Microbiologist will be responsible for implementing, maintaining, and overseeing the bioburden and endotoxin control programs across multiple manufacturing sites. This role will involve working closely with cross-functional teams to ensure compliance with regulatory standards as applicable and quality standards for Zeus' component manufacturing areas and Zeus' medical device manufacturing areas

Bioburden and Endotoxin Program Development: Develop, implement, and manage comprehensive bioburden and endotoxin control programs for all manufacturing sites, ensuring compliance with relevant regulatory requirements (e.g., FDA, ISO, USP).
Method Validation and Qualification: Working with external laboratories validate and qualify bioburden and endotoxin testing methods, ensuring accuracy and reliability of results.
Training and Education: Develop and deliver training and education to manufacturing personnel on contamination sources, testing procedures, control methods, regulatory requirements, and quality standards.
Data Analysis and Reporting: Review and analyze bioburden and endotoxin testing data, identify trends, coordinate additional testing as required, and prepare comprehensive reports for management.
Investigation and Root Cause Analysis: Investigate deviations from bioburden and endotoxin specifications, conduct root cause analyses, and implement corrective actions to prevent recurrence.
Risk Assessment and Mitigation: Conduct risk assessments to identify potential microbiological hazards and implement mitigation strategies.
Regulatory Compliance: Ensure compliance with all relevant regulatory requirements, including FDA, ISO, ANSI/ AAMI, and USP standards.
Continuous Improvement: Drive continuous improvement initiatives to enhance the effectiveness of contamination control programs.

Bachelor's degree in Microbiology, Biology, or a related field.
Minimum of 5 years of experience in a microbiology laboratory setting, preferably in the medical device or pharmaceutical industry.
Strong knowledge of LAL and bioburden testing methodologies, regulatory requirements, and quality standards.
Experience with validation and qualification of microbiological testing methods.
Excellent analytical and problem-solving skills.
Strong communication and interpersonal skills.
Ability to work independently and as part of a team.

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