Ryan Kavanagh Email & Phone Number

Greater Minneapolis-St. Paul Area

Project Management

Greater Minneapolis-St. Paul Area

• Provides work direction and supervision for the Microbiology laboratory staff• Primary front room subject matter expert (SME) for internal and external audits• Manages issue resolution related to Microbiology laboratory and cleanroom quality concerns• Liaison between Sterilization Services and Manufacturing Operations Management• Responsible for qualification activities related to the Cleanroom as well as overall contamination control and monitoring program• Delivers effective communication skills to interact closely between internal and external cross functional teams to ensure efficiency, compliance, and cost savings opportunities• Conducts classroom training to business partners• Responsible for adherence to industry standards• Develops work instructions, procedures, testing protocols and the environmental monitoring program • Creates and executes Equipment Installation/Operation/Performance Qualification protocols and reports• Collaborates with the Microbiology laboratory Test Method Validations team• Business owner and subject matter expert of the Vaisala Continuous Monitoring System. Responsible for equipment qualification, software validation and application configuration, process creation, user training, and overall implementation and maintenance of the system• Corrective and Preventive Actions (CAPA) owner

Greater Minneapolis-St. Paul Area

• Worked closely with Quality Engineers to ensure compliance to industry standards and issue resolution• Provided work direction, supervision and leadership for the Microbiology laboratory staff • Primary representative for internal and external audits

Greater Minneapolis-St. Paul Area

• Created the Rice Creek Central Controlled Environment Area qualification • Worked with cross functional teams to finalize qualification protocol and reports• Managed and maintain relationships with external contractors to facilitate various projects • Formulated testing protocols and reports for internal clients• Served as a liaison between manufacturing personnel and Sterilization Services• Supported development projects

Greater Minneapolis-St. Paul Area

• Analyzed customer complaint files to ensure proper completion for appropriate trending and coding to support post market surveillance

Greater Minneapolis-St. Paul Area

• Analyzed customer complaints to complete the FDA communication form

Greater Minneapolis-St. Paul Area

• Managed Microbiology laboratory duties and provided assistance to the Puerto Rico facility (Bioburden, LAL, Sterility testing, lethality testing)• Facilitated Environmental Monitoring for the Controlled Environment Area • Coordinated and led training for over 150 employees on Controlled Environment Area access protocols• Led monthly Controlled Environment Area committee meetings to develop key process improvements• Provided support for internal audits• Established networks with cross functional teams

Greater Minneapolis-St. Paul Area

• Performed analyses on client’s samples including Bioburden testing, LAL, and designed procedures for USP Sterility Testing• Executed analysis on sterility testing, results and reports displaying significance of analysis to clients• Supplied key information for external audits • Utilized the LIMS system for sample analysis and reporting• Revised Standard Operating Procedures

Master Of Business Administration (M.B.A.), Emphasis In Accounting

Bachelor’S Degree, Biology

Bachelor of Science degree in Biology with a minor in Chemistry