Microbiology Quality Control Supervisor

ROBERT BARKLEY

Quality Control Supervisor Microbiology Environmental Monitoring GMP Quality Systems

* ***** *** ******* ****** NJ, 07444 201-***-**** **************@*****.*** LinkedIn

PERSONAL SUMMARY

Results-driven Quality Control Microbiology Supervisor with progressive leadership experience overseeing Environmental Monitoring, microbiological testing, and GMP quality operations within FDA-regulated biopharmaceutical manufacturing environments. Proven expertise in leading high-performing teams, managing quality systems, and directing deviations, CAPAs, investigations, SOP development, risk assessments, and facility qualification activities while ensuring full compliance with FDA, cGMP, ISO, and ISPE standards. Demonstrated success in driving contamination control strategies, cleanroom qualification, environmental monitoring programs, and data-driven quality improvements that strengthen operational excellence and inspection readiness. Recognized for partnering cross-functionally to support product commercialization, regulatory approvals, and continuous process improvement while delivering the highest standards of quality, compliance, and operational performance.

CORE COMPETENCIES

Environmental Monitoring

QC Microbiology

GMP Compliance

Sterility Testing

Bioburden Testing

Cleanroom Qualification

Contamination Control

CAPA Management

Deviation Investigations

Risk Assessment

SOP Development

Utility Qualification

Microbial Identification

Team Leadership

Regulatory Compliance

KEY HIGHLIGHTS

Environmental Monitoring Leadership: Direct comprehensive Environmental Monitoring programs, cleanroom qualification, and contamination control initiatives that ensure GMP compliance, operational continuity, and inspection readiness.

Quality Systems Excellence: Lead deviations, CAPAs, investigations, SOP development, FMEAs, and risk assessments to strengthen quality systems, resolve complex issues, and drive continuous improvement.

Regulatory Compliance: Ensure adherence to FDA, cGMP, ISO, and ISPE requirements by maintaining robust quality processes, supporting audits, and contributing to successful regulatory inspections and product approvals.

Microbiology & Laboratory Operations: Oversee microbiological testing, utility qualification, equipment calibration, and laboratory operations to deliver accurate results, reliable processes, and efficient resource management.

People & Cross-Functional Leadership: Build high-performing teams and collaborate across Quality, Manufacturing, Engineering, and Validation to achieve production objectives, enhance operational performance, and foster a culture of quality.

WORK EXPERIENCES

BeOne Medicines (Formerly BeiGene) Hopewell, NJ Apr 2023- Present

Senior Analyst QC Environmental Monitoring

Environmental Monitoring Leadership: Direct the GMP Environmental Monitoring program, authoring SOPs and ensuring compliance with FDA, ISO, and ISPE standards.

Qualification & Risk Management: Develop EMPQ maps, risk assessments, and qualification documentation to support cleanroom and utility validation.

Quality Systems Oversight: Lead deviations, CAPAs, investigations, FMEAs, and PQ activities to strengthen compliance and operational excellence.

Laboratory Operations: Manage EM scheduling, equipment calibration, preventive maintenance, vendor coordination, and laboratory resources to ensure uninterrupted operations.

Team Leadership: Supervise and mentor four QC analysts, driving high-quality environmental monitoring and utility sampling while meeting testing timelines.

Gilead Sciences (Formerly Immunomedics) Morris Plains, NJ Jul 2019 – Apr 2023

Quality Control Microbiology Supervisor

Team Leadership: Led the QC Microbiology and Environmental Monitoring team, optimizing performance, training, and staffing to consistently achieve production and product release timelines.

Program Development: Partnered with cross-functional teams to execute EMPQs, IQ/OQ/PQs, and cleanroom qualifications, strengthening manufacturing readiness and GMP compliance.

Quality Systems Management: Directed deviations, CAPAs, investigations, SOPs, and risk assessments, driving effective issue resolution and continuous quality improvement.

Data Trending & Reporting: Published microbiology and environmental monitoring trend reports, delivering actionable insights to support contamination control and operational decisions.

Regulatory Subject Matter Expertise: Served as the QC Microbiology SME for the successful FDA approval of Trodelvy (2020), supporting regulatory readiness and inspection success.

Immunomedics Morris Plains, NJ Jun 2018 – Jul 2019

Quality Control Microbiologist

Microbiological Testing: Performed environmental monitoring, cleaning validation, water testing, bioburden, biological indicator, growth promotion, and microbial identification assays to support GMP manufacturing.

Investigation & CAPA Management: Investigated out-of-trend (OOT) and out-of-specification (OOS) results, leading CAPAs and quality investigations through Veeva to ensure timely issue resolution.

Laboratory Operations: Maintained laboratory readiness by coordinating equipment calibration, inventory management, and procurement of laboratory supplies and instrumentation.

Data Analysis & Trending: Generated environmental monitoring and microbial trend reports, providing data-driven insights to strengthen contamination control and quality performance.

Process Improvement: Initiated metrics-based investigations to identify microbial risks, implement corrective actions, and enhance environmental control within the manufacturing facility.

Gibraltar Laboratories (Gibraltar, GBL) Fairfield NJ Sep 2017 - May 2018

Microbiologist Environmental, Sterility testing and Bioburden testing

Microbiological Testing: Conducted environmental, sterility, bioburden, and water quality testing in accordance with ISO standards and GMP laboratory procedures.

Sample Analysis: Performed microbiological analyses on raw materials, in-process, and finished product samples, ensuring accurate, timely, and compliant test results.

Quality & Compliance: Maintained laboratory documentation, followed SOPs, and adhered to ISO and regulatory requirements to support audit and inspection readiness.

Laboratory Operations: Supported routine laboratory activities, including media preparation, equipment maintenance, and sample management to ensure efficient testing workflows.

Data Integrity: Documented, reviewed, and reported analytical results with a strong focus on data accuracy, traceability, and regulatory compliance.

ADDITIONAL EXPERIENCE

Loss Prevention Officer Glass Gardens Inc Morris, Bergen and Middlesex counties New Jersey Jan 2010 - Jul 2017

EDUCATION

Certificate in Biotechnology Biotechnology/ lab technician Fortis Institute Wayne NJ 2016 – 2017

LICENSES

Technical Writing and Documenting Investigations Instructor Led Training PathWise Issued May 2025

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