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The Microbiology Technician II will be responsible for performing environmental monitoring, quality control microbiological laboratory testing of in-process, finished goods, validation studies, and adherence to all applicable regulations, policies, and procedures purchased components, manufactured sub-assemblies and final product. Must have working knowledge of U.S. Food and Drug Administration regulations, ISO 13485, and other applicable regulatory agencies as they pertain to laboratory testing.

DESIRED MINIMUM QUALIFICATIONS

The requirements listed below are representative of the knowledge, skill, and/or ability required for this position.

• Bachelor’s degree in Microbiology, Biology, or a relevant scientific discipline.
• A minimum of 2-4 years’ experience in a medical device, pharmaceuticals, Quality/Regulatory Compliance, or other cGMP regulated product preferred environment.
• Familiarity with application of FDA and/or ISO quality standards in a government regulated industry. Quality Certification (e.g., CQE, CQA, Six Sigma) preferred.
• Proficient computer competence, including experience with database and Microsoft Office software to create reports, spreadsheets, analyze data and prepare presentations.
• Experience with performing Microbiological assays in cGMP compliance lab and understanding of aseptic techniques.
• Working knowledge of standard laboratory practices and safety.
• Ability to follow instructions precisely, recognize deviations, and recommend corrective action.
• Experience working in ISO Class 7 & 8 cleanrooms preferred.

To perform this job successfully, an individual must be able to perform each essential duty satisfactorily.

Primary responsibilities are to:

• Responsible for performing Microbiological testing such as Bioburden, Endotoxin, Gram staining, Growth promotion testing, TOC & Conductivity testing, sending samples for Microbial ID testing and other micro testing.
• Perform Environmental monitoring of clean rooms including Viables and Non-Viables testing and responsible of water samples collection and testing.
• Working knowledge of aseptic techniques and provides database support, generates reports, and analyzes the data as needed.
• Inspection and testing of raw materials, in-process, and final product testing.
• Assist in trending environmental monitoring data, Report and investigate any monitoring excursions.
• Monitors equipment and instrumentation used daily to ensure proper operation and calibration.
• Maintains a working inventory of all components, materials and solutions as needed.
• Develops and revises SOPs & Forms.
• Training of new hires.
• Responsible for identifying and alerting supervisor of issues on instruments and/or test executions; makes initial recommendations for possible solutions and/or corrective actions.
• Assist in Out of Specification (OOS) Investigations, Non-conformances, and Corrective Action/Preventive Actions (CAPAs).
• Assists in the writing and updating of Microbiological test procedures, protocol, logbooks, and checklists.
• Assist as needed in test method validation, investigation studies or other product development studies.
• Assist in preparing for and participating in FDA audits, customer audits, etc.
• All other duties as assigned