Manager, Microbiology Laboratory

POSITION SUMMARY:

This position will be responsible for the development, implementation, and management of a microbiology laboratory to support the testing requirements necessary for medical device manufacturing. The Microbiology Laboratory Manager is responsible for maintaining compliant material handling and testing processes to support product release, classified controlled environments, and utilities

Responsibilities include establishing direction, planning, coordinating, and ensuring the timely completion of daily operational tasks. These activities will include the development and implementation of a quality system for the Microbiology Laboratory to drive compliance to external standards and internal policies. The Microbiology Laboratory Manager is responsible achieving compliance to relevant standards and developing a robust Lab Management program and relevant documentation (SOP/WI/Forms).

This position will be responsible for the incorporation of testing within an internal laboratory, chain of custody and handling of lab test articles, test execution, and reporting results. In addition, the Microbiology Laboratory Manger will oversee training department staff, scheduling, and coordination of testing within the Microbiology Laboratory as well as reporting operational metrics, facilitating corrective actions, and implementing continuous improvement initiatives.

ESSENTIAL FUNCTIONS OF THE POSITION:

• Build world class quality system procedures and tools to administer a microbiology laboratory internally at AtriCure.
• Manage laboratory activities by providing quality leadership and direction to the team to ensure company objectives are met in a timely manner.
• Works within prescribed GMP/ISO/GLP Standards to develop, establish, validate, and implement compliant and efficient laboratory processes and controls.
• Mentor and train team members and coworkers to internal processes as well as applicable standards and regulations.
• Utilize proven techniques and knowledge of functional area to significantly contribute at the individual contributor and manager level.
• Develop and maintain lab metrics and maintain an adequate test turn-around time.
• Ensure data accuracy and integrity with appropriate techniques, supervise root cause analysis methods and corrective action investigations.
• Ensure laboratory logs and reports meet good documentation practices.
• Ensure calibration and maintenance of laboratory equipment.
• Ensure equipment qualifications and test method validations/verifications meet appliable standards, compendial methods (if appl.) and internal policies.
• Provide leadership, mentoring, and development plans for all direct reports to maintain an engaged and productive workforce.
• Perform management functions including interviewing candidates, performance reviews, etc.
• Effectively collaborate with laboratory personnel, sterilization, facilities, or other functional departments to problem solve, determine test strategy, and/or improve processes.
• Create continuous improvement and/ or cost saving/avoidance projects for implementing test methods internally and developing a laboratory management system.
• Compose and present summary reports to management summarizing activities, including trending and graphic representations.
• Participates in internal and external audits as subject matter expert for laboratory processes and activities

ADDITIONAL ESSENTIAL FUNCTIONS OF THE POSITION:

• Delivers results and drives continuous improvement
• Sets high performance goals and holds self-accountable for results
• Regular and predictable work performance
• On-site schedule - some weekend work as needed
• Ability to remain calm and receptive in fast-paced conditions
• Ability to make decisions and use good judgment
• Ability to prioritize various duties and multitask as required
• Support and/or perform external/internal audits as necessary
• Support laboratory personnel and miscellaneous duties
• Effective communication skills
• Ability to work in both collaborative and independent work situations and environments with minimal supervision

BASIC QUALIFICATIONS:

• Bachelor's degree in discipline such as Microbiology, Biology, or demonstrated equivalent combination of education, training, and experience.
• Working experience in regulated laboratory environment, with familiarity to cGMPs, 5 years minimum
• 3 years' experience in a management role.
• Management / Leadership Experience
• Workingknowledge of GMP/ISO/GLP guidelines as applied to laboratory practices.
• Knowledge of aseptic technique
• Experience in laboratory development
• Experience in equipment qualifications
• Experience with method validation
• General leadership skills to organize complex work schedules
• Ability to work with people and teams in a complex, changing environment and be able to deliver value added results to the business on time
• Fully competent in oral and written communications including strong documentation skills
• Strong critical thinking, problem solving and technical skills.
• Ability to prioritize multiple projects
• Computer/data entry skills
• Written/report writing skills
• Good interpersonal skills
• Intermediate Microsoft Office skills (Excel, Word, PowerPoint)
• Ability to travel 15%

PREFERRED QUALIFICATIONS:

• MS in Microbiology, biology or other relevant area of study
• FDA and ISO Audit experience
• Experience in medical device or pharmaceutical manufacturer setting
• Knowledge of ISO 13485 standard and Quality System experience
• Understanding of external standards; ISO 11737-1, ISO 11737-2, ISO 17025, FDA OOS Guidance, AAMI ST72, USP <85>, <161>
• Strong understanding of cGMPs
• Knowledge of controlled manufacturing environments and experience in monitoring and maintenance of systems validation using national and international standards

OTHER REQUIREMENTS:

• Ability to regularly walk, sit, or stand as needed
• Ability to occasionally bend and push/pull as needed
• Ability to regularly lift 25 pounds, occasionally lift up to 50 pounds
• Ability to pass pre-employment drug screen and background check