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The **Lead Microbiology Technician** will be responsible for supporting all activities in the Quality Control Microbiology team. This role also involves supporting non-conformance investigations, identifying root causes, and contributing to the continuous improvement of processes. Works collaboratively with Manufacturing, Engineering, Quality Assurance, and other functional experts to support all daily operational activities. Consults with management to resolve quality, production, and efficiency problems. Functions in conjunction with manager and functional experts on special department projects. Performs the essential duties and responsibilities as listed in section below.

ESSENTIAL DUTIES AND RESPONSIBILITIES** **:

+ Ensure all quality documentation is properly updated and completed in timely manner.

+ Collaborate with Quality Management to ensure all quality standards are met.

+ Provide support as needed for validations that involve microbiological testing, including EMPQ and Utilities qualifications.

+ Product testing (bio-burden, endotoxin, etc.), environmental monitoring of clean-rooms, clean-room gowning qualifications, utility testing (water, compressed air, etc.), Lab supplies purchasing, and laboratory projects.

+ Data entry and review.

+ Send out samples for external lab testing.

+ Perform and support investigating non-conformance's, identifying root causes, and implementing corrective actions.

+ Document and report quality control findings and support the analysis of data to recommend process improvements.

+ Prepare and/or support trending reports for quality control testing, environmental monitoring, and other laboratory testing as required.

+ Assist in training employees on quality standards, KPIs and procedures.

+ Support the implementation of new or improved quality control systems as needed.

+ Ensure compliance with industry regulations, company policies, and safety standards during the transition process.

+ Knowledge of industry standards and regulations related to Quality Control.

+ Maintains work areas and equipment in a clean and orderly condition.

+ Must be able to work in a Team environment, multi-task and communicate effectively.

+ Maintains a working inventory of all components and archived materials and solutions.

+ Assist as needed in test method validation, implementation, and execution.

+ Provides database support, generate reports and analyze process data.

+ Assist in preparing for, and participating in FDA audits, internal audits, and other regulatory agencies audits.

+ Demonstrate excellent organizational and time management skills.

+ Establish and maintain effective working relationships with those contacted in the course of work, work independently and in a team environment.

+ Perform other duties as required.

DESIRED MINIMUM QUALIFICATIONS:

+ High School Diploma or equivalent with 8+ years of experience required.

+ Bachelor's degree in microbiology, Biology or related field preferred.

+ 5+ years GMP/GLP laboratory experience in a medical device, pharmaceuticals, Quality/Regulatory Compliance, or other regulated industry

+ Familiarity with application of FDA and/or ISO quality standards in a government regulated industry.

+ Knowledge of QC terms, tools, and methodologies. Detail-oriented.

+ Strong verbal and written communication skills. Must be able to effectively present at staff and department meetings.

+ Moderate computer competence, including experience with database and Microsoft Office software to create reports, spreadsheets, analyze data and prepare presentations.

+ Working knowledge of standard Laboratory Practices and Safety.

+ Ability to follow instructions precisely, recognize deviations, and recommend corrective action.