Sr QC Micro Lab Operations Specialist

Role Summary

Sr QC Micro Lab Operations Specialist – Regeneron seeks a Quality Control Microbiology Laboratory Operations Specialist to execute projects, maintain compliance records and metrics, and provide inspection readiness support within QC. Responsible for assisting QC laboratories with investigations, deviations, method changes and document workflows.

Responsibilities

• Evaluates and implements new/updated techniques and procedures in the microbiology laboratory in terms of equipment, method comparison, software analysis, and data reporting to enhance microbiological testing and sampling efforts.
• Ensures that laboratory tests and procedures are consistent with accrediting regulatory agencies standards and requirements.
• Actively participate in cross-functional team meetings and communicate effectively and courteously with other team members to harmonize business operations.
• Oversees activities such as: complex laboratory investigations, instrument trouble shooting, creation/revision of laboratory procedures and implementation of new software systems/instrumentation and equipment.
• Ensures that all activities related to the investigation and resolutions of non-conformities are performed in a timely manner and in compliance with Regeneron procedures and regulatory requirements.
• Performs procedural gap analysis, identifies continuous improvement and lessons learned opportunities and implements solutions.
• Monitors and tracks department KPIs.
• Serves as Subject Matter Expert (SME) for laboratory operations and personnel.
• Executes and/or coordinates the completion of laboratory related protocols, both routine and atypical.
• Facilitates inspection readiness activities and participates in audits and inspections.
• May perform data review functions.
• Executes 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 data lifecycle; GMP pharmaceutical microbiology experience required.
• Preferred: Advanced knowledge in microbiological test methods (Endotoxin, Low Endotoxin Recovery, Bioburden, Sterility) for Drug Substance/Product, Gene Therapy, Raw Materials, Utilities and Disinfectants; experience with LIMS, Deviation Management Systems, Learning Management Systems; ability to interpret regulatory guidance and compendia.

Skills

• Strong analytical and problem-solving abilities
• Effective communication and cross-functional collaboration
• Proficiency with Microsoft Office; experience with LIMS and quality systems
• Ability to navigate regulatory guidance and quality/compliance frameworks

Education

• BS/BA in a scientific field (required)

Additional Requirements

• On-site work requirement (as per company policy; confirm with recruiter)