Quality Control Microbiology Specialist

Regeneron Pharmaceuticals•Rensselaer, IN

3d•$67,400 - $110,000•Onsite

About The Position

Regeneron is currently looking for a Quality Control Microbiology Lab Operations Specialist to join our QC team. The QC Microbiology team performs microbiological assays, related to clean room monitoring, utility monitoring, raw material, and product testing in accordance with Standard Operating Procedures (SOPs) and cGMP/FDA regulation. The specialist serves as a technical resource for microbiological methods, laboratory processes, and compliance-related activities while supporting operational excellence across the QC Microbiology organization.

Requirements

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.
BS/BA in Biology, Microbiology or related field, and 2+ years of relevant experience.
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.

Nice To Haves

Experience supporting regulatory inspections and audit readiness activities.
Experience in biologics, sterile manufacturing, or gene therapy environments.
Experience implementing new laboratory methods, instrumentation, software systems, or process improvements.
Demonstrated leadership in cross-functional project execution and continuous improvement initiatives.

Responsibilities

Serve as a technical resource and Subject Matter Expert (SME) 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 to improve testing effectiveness and operational efficiency.
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 are completed in compliance 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 applicable regulations and industry standards.
Monitor and analyze laboratory performance metrics and Key Performance Indicators (KPIs).
Identify and implement process improvements to enhance efficiency, compliance, data quality, and laboratory performance.
Support strategic initiatives aimed at improving microbiology testing, sampling programs, and laboratory operations.
Collaborate with internal stakeholders and external partners to resolve technical and operational challenges.