Microbiology QC Lab Lead - Operations & Compliance

Regeneron Pharmaceuticals; Rensselaer (IN); On-site; USD 67,000 - 110,000; Full time

Job summary

Regeneron Pharmaceuticals is seeking a Quality Control Microbiology Lab Operations Specialist to join our QC team in Rensselaer, NY. The role supports microbiological testing, SOPs, and cGMP compliance, serving as a SME for lab operations and methods.

You will evaluate new methods and equipment, lead investigations and CAPAs, and collaborate with cross-functional teams to improve testing efficiency and data integrity. This on-site position requires strong analytical and writing skills.

Qualifications

• BS/BA in Biology, Microbiology or related field with 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 LIMS/LMS and deviation management systems.
• Knowledge of cGMP, data integrity, and regulatory expectations.

Responsibilities

• Serve as SME for QC Microbiology laboratory operations 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, and technical assessments to improve testing efficiency and data quality.
• Represent QC Microbiology on cross-functional teams and project initiatives.
• Lead and support complex laboratory investigations, deviations, non-conformances, and root cause analyses.
• 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 and company procedures.
• 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.

Skills

Pharmaceutical microbiology

Microbiological testing methods

Analytical skills

Technical writing

Problem solving

Investigations & root cause analysis

Quality management systems

Laboratory software

MS Office

Education

BS/BA in Biology, Microbiology or related field

Tools

LIMS

LMS

Deviation management systems

Electronic Quality Management Systems

Job description

Regeneron Pharmaceuticals is seeking a Quality Control Microbiology Lab Operations Specialist to join our QC team in Rensselaer, NY. The role supports microbiological testing, SOPs, and cGMP compliance, serving as a SME for lab operations and methods.

You will evaluate new methods and equipment, lead investigations and CAPAs, and collaborate with cross-functional teams to improve testing efficiency and data integrity. This on-site position requires strong analytical and writing skills.