Manager, Quality Control Microbiology

Socket.dev; Miami (FL); On-site; USD 120,000 - 170,000; Full time

Benefits offered by this job

Medical, Dental & Vision Insurance

401(k) Retirement Plan

Paid Time Off

Life Insurance

Disability Insurance

Employee Assistance Program

Tuition Reimbursement

Job summary

BioTissue seeks a Manager of Quality Control Microbiology to oversee microbiology testing, environmental monitoring, and CAPA-driven investigations in a fast-paced cleanroom environment. You will lead training, ensure regulatory compliance, and provide SME support for audits and change controls.

The role demands strong leadership, cross-functional collaboration, and rigorous adherence to USP/ISO standards in a GMP/FDA setting. English fluency and proficiency with Word/Excel are required.

Qualifications

• In-depth knowledge of microbiology testing per USP and ISO standards (aseptic techniques, sterility, bioburden, environmental testing) in GMP/FDA environments.
• Strong Quality Control background in a cGMP/FDA regulated setting.
• Ability to manage multiple projects and priorities in a fast-paced environment.
• Proven people leadership and communication skills; demonstrate BioTissue core values.
• Ability to lead cross-functional teams and influence stakeholders at multiple levels.

Responsibilities

• Oversee daily microbiology operations including scheduling, training, EM sampling, and incubation.
• Oversee aseptic manufacturing in a cleanroom per SOPs.
• Maintain training programs for gowning and aseptic techniques.
• Provide technical oversight in microbiological methods (EM, sterility, bioburden, endotoxin).
• Manage media fills, EMPQs, and Cleanroom validations.
• Conduct trend analysis of EM data and review test results for release.
• Maintain media and reagent inventory and support audits as SME.
• Lead investigations into QEs, OOSs, NCRs, change controls, and CAPAs.
• Assist in developing and updating SOPs/WIs related to microbiological testing.

Skills

USP/ISO microbiology

cGMP/FDA

Leadership

Cross-functional

Communication

MS Word & Excel

Problem solving

Education

BS/MS in Biology/Biochemistry/Microbiology

Job description

About BioTissue & our Culture

At BioTissue, 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.

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[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.

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.

Physical Requirements

• Sedentary work that generally requires sitting and/or standing.

Total Rewards

At BioTissue, we believe our people are our greatest asset. We offer a comprehensive Total Rewards package designed to support employees' health, financial wellbeing, professional growth, and work-life balance.

Our benefits may include:

• Medical, Dental, and Vision Insurance
• Health Savings Account (HSA) and Flexible Spending Accounts (FSA)
• 401(k) Retirement Savings Plan
• Company-Paid Basic Life and AD&D Insurance
• Voluntary Life and AD&D Insurance
• Short-Term and Long-Term Disability Coverage
• Employee Assistance Program (EAP)
• Legal and Identity Protection Benefits
• Pet Insurance
• Paid Time Off and Company Holidays
• Paid Parental and Birthing Leave
• Family and Medical Leave (FMLA), where applicable
• Tuition Reimbursement and Professional Development Support
• Performance-Based Incentive Opportunities
• Equity or Stock Programs, where applicable

Benefits eligibility and offerings may vary based on position, location, and employment status.

ADA Statement

BioTissue is committed to providing reasonable accommodations to qualified individuals with disabilities throughout the hiring process and employment lifecycle. If you require assistance or accommodation to participate in the application process or perform the essential functions of a position, please contact us to discuss your needs.

Qualified applicants with disabilities will be considered for employment and may be eligible to perform the essential functions of the position with or without reasonable accommodation.

Equal Employment Opportunity

BioTissue is committed to fostering a workplace where everyone feels valued, respected, and empowered to contribute. We welcome applicants from diverse backgrounds and experiences and are proud to be an Equal Opportunity Employer. Employment decisions are based on qualifications, merit, and business needs, without regard to any legally protected characteristic.