Lab Technician II

Job Description

Duties and Responsibilities:

• Responsible for performing Microbiological testing such as Bioburden, Endotoxin, Growth promotion testing, TOC & Conductivity testing, sending samples for Microbial ID testing and other micro testing.
• Perform Environmental monitoring of clean rooms including Viable and Non-viable 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.
• 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.

Education &  Experience:

• 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.
• Experience working in ISO Class 7 & 8 cleanrooms preferred.
• Experience with Bioburden testing is great.
• Microsoft Office experience – Advanced/Proficient.

Knowledge & Skills:

• Working knowledge of standard laboratory practices and safety.
• Ability to follow instructions precisely, recognize deviations, and recommend corrective action.
• Environmental Monitoring.
• Water Monitor & Collecting.