Manager, Quality Control Microbiology

About Bio Tissue & our Culture

At Bio Tissue, we transform the gift of life by sharing miracles. We are a diverse community, where talent and teamwork are core to who we are. Here, you are EMPOWERED to do the work you love, be yourself, and make an impact. Resilient and committed to our vision, we embrace challenges, celebrate courage, and take great pride in our work to create life-changing products.

Purpose led us here. Passion and legacy keep us going.

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.

• 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[LC2], 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.[LC3][KS4]
• 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.

• 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 Bio Tissue’s Core Values and Leadership Commitments
• The role requires strong and visible leadership presence with accountability for setting direction,…