JOB OVERVIEW
1. Develop and execute plans to expand QC laboratory capabilities for microbiology, to include, but not limited to:
a. identification and purchase of necessary equipment
b. writing, coordinating and performance of equipment qualifications
c. development and/or revision of new or improved microbiological methodologies
d. writing, coordinating and performance of validation of microbiological methodologies
e. development of standard operating procedures
f. establishment of database for test results
g. management of microbiology laboratory
2. Perform routine microbiological testing:
a. product and water system bioburden
b. biological indicator (BI) testing for sterility
c. BI population verification
d. product sterility
e. material and product cytotoxicity
f. endotoxin testing
g. environment monitoring
3. Ensure that all the samples are tested according to specified methods and devise a system to ensure full traceability of the samples.
4. Review, analyze and interpret data from samples.
5. Subject Matter Expert for microbiology.
6. Lead and support research and development and method development efforts.
7. Develop or assist in developing experimental designs and test plans.
8. Perform regular site microbiological assessment which covers manufacturing processes, manufacturing environment, raw material receipt and handling systems, process water systems and hygienic practices.
9. Define and ensure the training of relevant personnel to required microbiological techniques.
10. Travel to other STAAR facilities, as required.
11. Perform additional duties as assigned
EDUCATION & TRAINING
• Minimum of a Bachelor of Science (BS) degree in Microbiology or equivalent combination of education/experience.
• Master’s Degree preferred.
EXPERIENCE
• Minimum eight years working experience as a Microbiologist in the medical device, pharmaceutical or biologics industry, with experience in the practical application of microbiology techniques, FDA Quality System Regulation and ISO 13485 or equivalent, required
• Working experience with and understanding of industry best laboratory practices, techniques, equipment, materials and mathematical calculations, required.
• Experience with development, writing and execution of equipment qualifications and method validations, required.
• Experience in implementation and management of microbiology laboratory, required.
SKILLS
• Understanding and knowledge of current and emerging bioanalytical tools and techniques, required.
• Excellent project management, organization, writing, communication and presentation skills required.
• Ability to develop, write, execute qualification/validation protocols and reports.
• Ability to compile, analyze, graph, and compare data using standard statistical techniques (i.e., t-tests, ANOVA, linear regression analysis, etc.).
• Ability to work well independently and in a team-based environment.
• A high level of initiative and leadership capabilities.
• Demonstrated expert knowledge of Windows-based software, including Word, Excel, Access, Project, and Power Point.
• Proficiency in written and spoken English required.
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