Manager, Quality Control Microbiology

Position Summary

The Manager of Quality Control Microbiology is responsible for oversight of microbiology testing and environmental monitoring (EM) of the Clean Room facility and other pertinent areas. This position is also responsible for trending related microbiology performance data and conducting investigations related to Quality Events (QEs), Out of Specifications (OOSs), non-conformances, change control events and CAPAs. This position will lead training which will include facility aseptic training, environmental monitoring, and aseptic gowning as needed.

Essential Duties & Responsibilities

• Manage daily microbiology operations including scheduling, training, environmental monitoring, as well as incubation and inspection of EM samples.
• Oversee aseptic manufacturing of human tissue-based products and medical devices in a cleanroom according to established Standard Operating Procedures (SOPs).
• Maintains training programs for gowning qualifications, aseptic techniques and environmental monitoring.
• Provide technical oversight in microbiological techniques such as Aseptic Technique, Environmental Monitoring, Growth Promotion Testing, Bioburden Testing, Sterility Testing and Endotoxin Testing.
• Manage the execution of Media Fills, Environmental Monitoring Performance Qualifications (EMPQs) and Cleanroom Validations.
• Conduct trend analysis, track and trend EM data to ensure samples were within limits.
• Review and approve environmental monitoring forms, Quality Control (QC) logbooks and EM test results to ensure quality criteria are met prior to product release.
• Maintain media and reagents inventory as needed for daily microbiological testing.
• Manage priorities and schedules such that individual goals as well as team goals are achieved.
• Complete microbiological risk assessment ensuring alignment with regulatory requirements.
• Support audits as the Subject Matter Expert (SME) for environmental monitoring and microbiological activities, to ensure the concepts, objectives and requirements of a Quality Management System (QMS) are maintained.
• Conduct review of microbiology testing requirements support the release of all distributable products to ensure compliance with applicable regulations and company procedures.
• Conduct investigations related to Quality Events (QEs), Out of Specifications (OOSs), non-conformances, change control events and Corrective Actions and Preventive Actions (CAPAs).
• Assist in the development, revision and implementation of SOPs and Work Instructions (WIs) as applicable to microbiological testing.

Skills & Abilities

• In-depth knowledge of microbiology testing per United States Pharmacopeia (USP) and International Organization for Standardization (ISO) standards including aseptic techniques, sterility testing, bioburden testing and environmental testing.
• Strong Quality Control background within a current Good Manufacturing Practice (cGMP) and United States Food and Drug Administration (FDA) regulated environment.
• Ability to manage multiple projects and priorities in a fast-paced environment.
• Strong and proven people leadership and communication skills, and the ability to model BioTissue’s Core Values and Leadership Commitments.
• The role requires strong and visible leadership presence with accountability for setting direction, driving execution, and fostering a culture of ownership, collaboration, and continuous improvement.
• The incumbent must demonstrate the ability to lead cross-functional teams, influence stakeholders at multiple levels, make timely and sound decisions, and develop talent through coaching, feedback, and clear performance expectations.
• This role must emphasize not only technical competence, but also the ability to inspire confidence, manage change effectively, resolve issues with urgency, and uphold high standards of quality, compliance, and business performance.
• Ability to identify and solve technical problems and to react quickly and decisively in unexpected dynamic situations.
• Fluent (oral/written) English.
• Computer Proficiency – Word and Excel.

Position Expertise/Qualifications

• Bachelor of Science or Master of Science in Biology, Biochemistry, Microbiology or related field, required.
• 5-7 years of microbiology experience in GMP operations and /or quality operations, required.
• 1-2 years in a managerial role.