Microbiology Supervisor

POSITION SUMMARY:

Reporting to the Director of Microbiology, the QC Microbiology Supervisor is responsible for overseeing the daily operations of the Quality Control Microbiology laboratory, ensuring compliance with cGMP regulations and company quality standards. This role includes supervising a team of Associates and Specialists, performing, and reviewing microbiological testing, overseeing laboratory equipment and supplies, and contributing to the development and implementation of quality systems. The Supervisor will also be responsible for data analysis, trend identification, and troubleshooting investigations related to microbiological excursions. This position requires strong leadership, technical expertise in microbiology, and a commitment to quality and continuous improvement.

PRINCIPAL DUTIES:

Execution of Microbiology Department Specific Tasks:

• Extensive experience in Microbiology and EM groups and can lead actively and / or participate in technical projects pertaining to microbiology related testing processes, including but not limited to method development, transfer and validation activities, sanitization studies, media fill qualification activities, etc.
• Reviews process and testing documentation as needed to ensure complete and accurate records are maintained.
• Performs method validation/suitability for microbiological tests, specifically bioburden and sterility testing.
• Performs trending analyses of data collected via environmental, personnel and utility monitoring in support of investigations, Quality Management Review, Annual Product Review, etc.; publish conclusions and make recommendations for process changes as applicable.
• Investigates and documents any identified excursions or trends, including root cause analysis, impact assessment, and identification of corrective I preventive actions.
• Plans and implements corrective and preventive actions (including procedure and test method revisions), and assists/measures the effectiveness of such changes.
• Prepares weekly Environmental Monitoring/ Testing schedule.
• Reviews and approves Bioburden, B&F, and Sterility testing reports.
• Provides leadership, management, training, and career coaching for Micro Lab staff.
• Oversee Gowning Qualification program at Pyramid Laboratories.
• Authors technical protocols and reports for QC Microbiology.
• Assists management in establishing operational objectives, goals, and project assignments.
• Works through and solves complex projects/problems, where data and situation analysis are required.

Process Optimization

• Assesses processes and procedure changes proposed by others for potential impact on environmental monitoring I microbiology testing processes.
• Identifies inefficiencies in Microbiology workflows, communicates with quality leadership, and assists in implementation of improvements to enhance speed, accuracy, and compliance.
• Participate in cross-functional meetings when needed and training sessions with manufacturing operations.

Laboratory Support Activities:

• Maintains qualification for all microbiology sampling procedures and test methods; performs testing as needed to support business needs.
• Coordinates and/or conducts training for new laboratory personnel; provides technical assistance to laboratory personnel as needed.
• Coordinates with contracts testing laboratories and experts as needed.

Compliance & Audits:

Ensure adherence to regulatory standards (e.g., FDA, ISO, GMP) and participate in internal audits and external inspections.

Cross-Functional Collaboration:

• Partner with manufacturing, R&D, and supply chain teams to ensure quality is embedded throughout the product lifecycle.
• Regularly interacts with senior management or executive levels on matters concerning several functional areas, divisions, and/or customers.

Metrics & Reporting:

Develop and track KPI for Microbiology Performance presenting insights and recommendations to senior leadership.

• Responsible for implementing LEAN concepts to continuously improve cycle times within the area of responsibility .
• Responsible for management of investigations, CAPAs, change control, requalification, and product annual review in the microbiology area.
• Reviews data, to verify that ALCOA++ principles are being followed, accurate and in control before reporting.
• Report nonconformances and follow escalation pathways.

• Provide support and information as SME for the Pyramid facility during external and regulatory inspections.
• May perform other duties as assigned.

JOB REQUIREMENTS:

Demonstrates proficiency in multiple quality systems including Deviation, CAPA and Out-of Specification management, Change Control, etc. with strong decision-making skills utilizing risk management.

• Strong verbal, written and oral communication skills.
• Strong knowledge of cGMP (US, EU, etc.) required
• Strong knowledge of manufacturing processes (Formulation, Filling, Packaging) and/or critical systems required.
• Able to present areas of responsibility to regulatory agencies during inspections or external audits.
• Proficient in problem solving using continuous improvement tools.
• Attention to detail and strong documentation skills.
• Team player with a continuous-improvement mindset.
• Must have the following personal attributes: integrity and trust, work ethic, sound judgment, intellectual honesty, pragmatism, courage, and conviction.
• Must display personal accountability for results and integrity.
• Must display eagerness to learn and continuously improve.
• Must have uncompromising dedication to quality.
• Must have relentless focus on rapid and disciplined action.
• Must have respect for individuals and the diverse contributions of all.

EDUCATION and/or EXPERIENCE:

• Bachelor's degree in biology, Chemistry, Pharmaceutical Sciences, Engineering, or equivalent experience preferred; or AS with relevant experience
• 3+ years of GMP/pharmaceutical experience preferred; experience in sterile or aseptic environments preferred.