Quality Microbiology Lead

Job Summary

MycoWorks is seeking a person to fill the role of Quality Microbiology Lead. They will be responsible for  taking ownership of systems and serving as subject matter expert for all quality microbiological sampling and testing, including raw materials, in-process materials and Environmental Monitoring. This position will also provide strategic guidance and support to both the Manufacturing and Technology Development teams in creating test protocols, planning testing, documenting processes and procedures and tracking results.

The role reports to the Senior Quality Manager and will work collaboratively with both Technology Development and Manufacturing.

Responsibilities:

• Take leadership in managing technicians to ensure smooth operations
• Build and execute systems for all aspects of micro sample collection, airborne contaminant monitoring, surface contaminant monitoring, contaminant identification and countermeasures
• Provide technical training to functional team members on microbiological sampling and testing, media plating, enumeration, data reporting, etc.
• Develop, implement, and maintain a comprehensive environmental monitoring program for the manufacturing plant and laboratories, focusing on strategic objectives
• Establish and enforce standard operating procedures (SOPs) and protocols for microbiology testing and environmental monitoring activities aligning them with quality requirements and business objectives
• Strategically design sampling plans for air, water, surfaces, and other critical areas as per regulatory and quality requirements
• Oversee routine and non-routine environmental monitoring activities, including sample collection, data analysis, and result interpretation with a focus on system improvement
• Provide framework for investigating  and resolving deviations, non-conformances, and environmental excursions, implementing corrective and preventive actions (CAPAs)
• Prepare and present reports summarizing sampling results, trends, and compliance status to relevant stakeholders, highlighting strategic insights
• Identify areas for improvement and implement strategies to enhance the effectiveness and efficiency of environmental monitoring processes
• Oversee inventory of media and material required and ensure supplies are ordered as necessary
• Strategically schedule microbiology workload to meet department/site requirements
• Lead and support gown qualification and gown training
• Oversee SOP writing for lab operations, testing protocols, and test validation 
• Lead process and method validation, and development of analytical methods
• Oversee and ensure the safety of lab operations including microbiological safety on a daily basis 
• Oversee lab equipment calibration and performance to ensure the accuracy of test results

Qualifications:

• A minimum of a Bachelor's degree in Microbiology or a related scientific discipline is required.  Equivalent experience may be accepted
• Two to three years of previous experience as a lead is preferred
• Five plus years of previous Lab Analyst, Technician, Lab Associate experience, preferably in a regulated environment - food, consumer products, life science, health
• Experience designing and executing microbiological testing (i.e., total plate count), Environmental Monitoring Program, and scheduling
• Experience with gowning procedures, aseptic technique and contamination control within a clean room environment is required
• Familiarity with lab systems is preferred, LIMS, ELN, LES, sample management, instrument management, calibration scheduling and management
• Excellent capability with MS Office / GSuite tools, data reporting and statistical analysis
• Familiarity with statistical-guided experimental design and analysis (e.g. DoE) is a plus 
• Strong verbal and written communication skills
• Good laboratory compliance and safety practices are a must

Our job titles may span more than one career level. The targeted base pay for this role is $86,000-$92,500 . The actual pay is dependent on other factors such as training, skills, work experience and business needs. The target pay range is subject to change and may be modified. This role is also eligible for benefits and equity.

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