Sr QC Micro Lab Operations Specialist

Role Summary

Regeneron is seeking a QC Microbiology Laboratory Operations Specialist to support quality control microbiology activities, maintain compliance records and metrics, and provide inspection readiness assistance within QC. The role involves assisting QC laboratories with investigations, deviations, method changes, and document workflows.

Responsibilities

• Evaluates and implements new or updated techniques and procedures in the microbiology laboratory related to equipment, method comparison, software analysis, and data reporting to enhance testing and sampling.
• Ensure laboratory tests and procedures are aligned with accrediting regulatory agency standards and requirements.
• Participate in cross-functional team meetings and communicate effectively to harmonize operations.
• Oversee activities such as complex laboratory investigations, instrument troubleshooting, creation/revision of laboratory procedures, and implementation of new software systems, instrumentation, and equipment.
• Ensure timely investigation and resolution of non-conformities in compliance with Regeneron procedures and regulatory requirements.
• Perform procedural gap analyses and implement continuous improvement opportunities and lessons learned.
• Monitor and track department KPIs.
• Serve as Subject Matter Expert for laboratory operations and personnel.
• Execute and coordinate laboratory-related protocols, both routine and atypical.
• Facilitate inspection readiness activities and participate in audits and inspections.
• May perform data review functions.
• Execute Change Controls, CAPAs, and document workflows in electronic quality and document management systems.

Qualifications

• Required: BS/BA in a scientific field and 5+ years of related experience or equivalent combination of education and experience; strong understanding of data integrity and GMP pharmaceutical microbiology experience.
• Preferred: Advanced knowledge in microbiological test methods (Endotoxin, Low Endotoxin Recovery, Bioburden, Sterility) across Drug Substance, Drug Product, Gene Therapy, Raw Materials, Utilities, and Disinfectants.
• Ability to navigate and interpret regulatory guidance and compendia.

Skills

• Laboratory operations and QA/document control systems proficiency
• Microsoft Office Suite (Word, Excel, PowerPoint), LIMS, Deviation Management Systems, Learning Management Systems
• Strong communication and teamwork abilities
• Analytical thinking and problem-solving; ability to develop metrics and improvements

Education

• BS/BA in a scientific field

Additional Requirements

• On-site work Monday-Friday, 8am-4:30pm (location-dependent).