Quality Control Microbiology Analyst

Regeneron Pharmaceuticals • Rensselaer, IN

3d • $25 - $39 • Onsite

About The Position

Regeneron is hiring a Quality Control Microbiology Analyst to perform microbiological assays in accordance with Standard Operating Procedures and cGMP/FDA regulations. The role primarily performs routine environmental monitoring for drug substance and drug product manufacturing areas, utility sampling and testing, gowning and aseptic qualifications, and testing of raw materials, in-process materials, and finished products related to drug manufacturing.

The position is based in Rensselaer, New York, and works Sunday through Wednesday on the first shift, from 6:00 a.m. to 2:30 p.m. Work takes place in a cleanroom environment and requires full cleanroom attire. The role level is determined by experience and qualifications relevant to the position.

Requirements

• Bachelor of Science or Bachelor of Arts degree in Microbiology, Biology, or a related field.
• At least 12–18 months of related experience.
• Strong decision-making and problem-solving skills.
• Working knowledge of Microsoft Suite applications, including Word, Excel, and PowerPoint; a Laboratory Information Management System (LIMS); Deviation Management Systems; and Learning Management Systems.
• Ability to wear full cleanroom attire, which may include laundered undergarments, gown, facemask, hairnet, safety glasses, safety shoes and booties, and latex gloves, and to use sanitizing agents such as IPA during gowning.
• Ability to remove jewelry, makeup, and nail adornments when wearing cleanroom attire.
• Ability to perform physical requirements for the entirety of a shift, up to 10 hours, in a cleanroom environment. Physical requirements may include bending, climbing, crawling, kneeling, reaching, reaching overhead, sitting, squatting, walking, standing, driving, hand manipulation, and lifting, pushing, or pulling up to 50 pounds.

Nice To Haves

• Prior GMP microbiology experience related to drug substance (bulk) or drug product (fill/finish) manufacturing.

Responsibilities

• Monitor controlled environments, personnel, and clean utilities.
• Perform microbiological testing and analysis, including bioburden testing, endotoxin content testing, plate enumeration, and growth promotion, on samples related to environmental monitoring, utilities, raw materials, and in-process and final products.
• Perform gowning and aseptic qualifications for personnel.
• Train employees.
• Peer review data.
• Prepare technical documents, including SOPs, protocols, reports, trend reports, risk assessments, laboratory investigations, and change controls.
• Develop and drive scientific and/or business-related improvement ideas.

Benefits

• Competitive and comprehensive total rewards package, which may include annual bonuses or other incentive plans, equity awards, pension or retirement benefits, 401(k) company match, health and wellness programs, fitness centers, insurance benefits such as medical, dental, vision, life, and disability coverage, paid time off, and family support benefits.

What This Job Offers

• Job Type: Full-time
• Career Level: Entry Level