Quality Control Microbiology Specialist

Regeneron Pharmaceuticals; Rensselaer (IN); Vor Ort; USD 67.000 - 110.000; Vollzeit

Zusammenfassung

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.

Qualifikationen

• 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.

Aufgaben

• 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.

Kenntnisse

Pharmaceutical microbiology

Microbiological testing methods

Analytical skills

Technical writing

Problem solving

Investigations & root cause analysis

Quality management systems

Laboratory software

MS Office

Ausbildung

BS/BA in Biology, Microbiology or related field

Tools

LIMS

LMS

Deviation management systems

Electronic Quality Management Systems

Jobbeschreibung

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.

When & where:

• Monday–Friday, 8:00am–4:30pm
• Location: Rensselaer, New York, United States

Discover your role:

• 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.
• 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.

This role requires:

• 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.

Preferred experience

• 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.

Level is determined based on qualifications relevant to the role.

Does this sound like you? We are committed to building a workplace with an inclusive culture. Regeneron is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion or belief (or lack thereof), sex, sexual orientation, gender identity or expression, gender reassignment, marital or civil partnership status, civil status, pregnancy or parental status, age, disability, nationality, citizenship status, ethnic or national origin, membership of the Traveler community, familial status, genetic information, military or veteran status, or any other characteristic protected under applicable law. Where required, we will provide reasonable accommodation to applicants with known disabilities or chronic illnesses during the recruitment process, unless such accommodation would impose undue hardship.

Where necessary, we disclose salary ranges for roles in all countries in which we operate. The final offer will be determined within the relevant range based on the country of employment, specific role level, and your skills and experience. In some countries, collective bargaining agreements (CBAs) may apply and influence certain elements of pay or benefits. Regeneron offers a competitive and comprehensive total rewards package which may include, depending on country and role: annual bonuses or other incentive plans, equity awards, pension or retirement benefits, 401(k) company match, health and wellness programs, fitness centers, insurance benefits (e.g. medical, dental, vision, life and disability), paid time off, and family support benefits. For additional information about Regeneron benefits in the U.S., please visit https://careers.regeneron.com/en/working-at-regeneron/total-rewards/. For other locations, additional information will be provided during the recruitment process.

Please be advised that at Regeneron, we believe we do our best work when we are together. For that reason, many roles are required to be performed on‑site.

As part of the recruitment process, certain background checks may be conducted in accordance with the laws of the country where the position is based. The purpose of such checks is to verify certain information prior to the commencement of employment such as identity, right to work and educational qualifications.

For jobs in Canada: this posting is for an existing position.

Salary Range (annually)

$67,400.00 - $110,000.00