Quality Control Microbiology Specialist

Regeneron

. Serve as a technical resource and Subject Matter Expert for QC Microbiology laboratory operations, microbiological methods, and testing programs .

Posted 9/15/2026full-timeRensselaer • New York • United StatesJuniorMid-Level💰 $67,400 - $110,000 per yearWebsite

Core Competencies

Role fit

Core Competencies

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Demonstrates advanced knowledge of pharmaceutical microbiology principles and practices, including microbiological testing methods and cGMP regulations. Proficient in conducting laboratory investigations, technical writing, and implementing quality systems to ensure compliance and enhance laboratory performance.

Highest-signal resume keywords

Microbiological Testing MethodsCGMP RegulationsLaboratory InvestigationsChange Control ManagementElectronic Quality Management Systems

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills

Microbiological MethodsData AnalysisTechnical WritingRoot Cause AnalysisQuality System Records ManagementLaboratory Performance MetricsProcess ImprovementSOP AuthoringRegulatory ComplianceTrend Analysis

Soft Skills

Problem-SolvingCollaborationLeadershipAnalytical ThinkingCommunication

Tools & Technologies

Laboratory Information Management Systems (LIMS)Learning Management Systems (LMS)Electronic Quality Management SystemsMicrosoft Office Applications

Industry Keywords

Pharmaceutical MicrobiologyQuality Control (QC)BiologicsSterile ManufacturingGene TherapyRegulatory InspectionsAudit ReadinessData IntegrityEnvironmental MonitoringUtility Monitoring

About the role

Key responsibilities & impact

Serve as a technical resource and Subject Matter Expert for QC Microbiology laboratory operations, microbiological methods, and testing programs
Evaluate, implement, and support new or revised microbiological methods, laboratory procedures, equipment, software applications, and reporting tools
Lead and support laboratory studies, protocols, troubleshooting efforts, and technical assessments
Represent QC Microbiology on cross-functional teams and project initiatives
Lead and support complex laboratory investigations, deviations, non-conformances, and root cause analyses
Perform data gathering, trend analysis, and technical assessments to support investigations and business decisions
Initiate, execute, and close quality system records including Change Controls, CAPAs, deviations, and document revisions
Ensure investigations and quality system activities comply with cGMP requirements, company procedures, and regulatory expectations
Author, revise, and review SOPs, technical reports, protocols, risk assessments, and other controlled documents
Facilitate inspection readiness activities and participate in internal audits, regulatory inspections, and client audits
Monitor regulatory and technical updates and incorporate applicable changes into laboratory procedures and practices
Ensure laboratory activities, documentation, and data integrity practices remain compliant with regulations and industry standards
Monitor and analyze laboratory performance metrics and KPIs
Identify and implement process improvements to enhance efficiency, compliance, data quality, and laboratory performance
Support strategic initiatives improving microbiology testing, sampling programs, and laboratory operations
Collaborate with internal stakeholders and external partners to resolve technical and operational challenges

Requirements

What you’ll need

BS/BA in Biology, Microbiology, or related field, and 2+ years of relevant experience
Advanced knowledge of pharmaceutical microbiology principles and practices
Advanced knowledge of microbiological testing methods including endotoxin, sterility, bioburden, environmental monitoring, utility monitoring, and raw material testing
Understanding of cGMP regulations, data integrity requirements, and laboratory compliance expectations
Ability to navigate and interpret regulatory guidance documents and compendial requirements
Experience conducting laboratory investigations and root cause analyses
Knowledge of Change Control, CAPA, deviation management, and quality systems
Strong analytical, technical writing, and problem-solving skills
Experience with electronic quality management systems and laboratory software applications
Proficiency with Microsoft Office applications (Word, Excel, PowerPoint)
Working knowledge of Laboratory Information Management Systems (LIMS), Learning Management Systems (LMS), and deviation management systems
Preferred: experience supporting regulatory inspections and audit readiness activities
Preferred: experience in biologics, sterile manufacturing, or gene therapy environments
Preferred: experience implementing new laboratory methods, instrumentation, software systems, or process improvements
Preferred: demonstrated leadership in cross-functional project execution and continuous improvement initiatives

Benefits

Comp & perks

Annual bonuses or other incentive plans
Equity awards
Pension or retirement benefits
401(k) company match
Health and wellness programs
Fitness centers
Medical, dental, vision, life, and disability insurance benefits
Paid time off
Family support benefits
Reasonable accommodation during the recruitment process where required