Quality Control Microbiology Analyst

About the Role

Regeneron is seeking a Quality Control (QC) Microbiology Analyst to perform microbiological assays related to clean room monitoring, utility monitoring, raw material, and product testing in accordance with Standard Operating Procedures (SOPs) and cGMP/FDA regulations. This role is primarily responsible for routine environmental monitoring, utilities sampling and testing, gowning and aseptic qualifications, and raw materials, in-process, and finished product testing related to drug manufacturing.

Responsibilities

• Environmental monitoring of controlled environments, personnel, and clean utilities.
• Microbiological testing and analysis (bioburden testing, endotoxin content testing, plate enumeration, growth promotion, etc.) on various sample types.
• Performing gowning and aseptic qualifications for personnel.
• Training of employees.
• Peer review of data.
• Technical writing assignments such as SOPs, protocols, reports, trend reports, risk assessments, laboratory investigations, and change controls.
• Developing and driving scientific and/or business-related improvement ideas.

Qualifications

• BS/BA in Microbiology, Biology, or a related field.
• Minimum of 12-18+ months of related experience.
• Prior GMP experience in Microbiology related to drug substance (bulk) or drug product (fill/finish) manufacturing is preferred.

Skills

• Strong decision-making and problem-solving skills.
• Working knowledge of Microsoft Suite applications (Word, Excel, PowerPoint), Laboratory Information Management System (LIMS), Deviation Management Systems, and Learning Management Systems.

Schedule

Sunday-Wednesday, 1st shift: 6:00 AM - 2:30 PM

Location

Rensselaer, New York, United States

Physical Requirements

• Ability to perform physical tasks for the entirety of the shift (up to 10 hours) in a clean room environment.
• Tasks may include bending, climbing, crawling, kneeling, reaching, reaching overhead, sitting, squatting, walking, standing, driving, hand manipulation, and lifting/pushing/pulling up to 50 lbs.
• Full cleanroom attire is required, including laundered undergarments, gown, facemask, hairnet, safety glasses, safety shoes, booties, latex gloves, and the use of sanitizing agents during the gowning process.
• Ability to remove jewelry, make-up, and nail adornments when wearing cleanroom attire.

Pay

Salary Range (hourly): $24.76 - $38.70