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 (SOPs) and cGMP/FDA regulations. The role primarily supports drug substance and drug product manufacturing through routine environmental monitoring, utility sampling and testing, personnel gowning and aseptic qualifications, and testing of raw materials, in-process materials, and finished products.

The position works Sunday through Wednesday, 1:00 p.m. to 11:30 p.m., in Rensselaer, New York. Work requires wearing full cleanroom attire and performing physical tasks for up to 10 hours in a cleanroom environment. The role level will be determined based on relevant experience and qualifications.

Requirements

• BS/BA in Microbiology, Biology, or a related field.
• A minimum of 12–18+ months of related experience.
• Working knowledge of Microsoft Suite applications (Word, Excel, and PowerPoint), a Laboratory Information Management System (LIMS), Deviation Management Systems, and Learning Management Systems.
• Ability to perform physical requirements for up to 10 hours in a cleanroom environment.
• Ability to wear full cleanroom attire, which may include laundered undergarments, gown, facemask, hairnet, safety glasses, safety shoes and booties, latex gloves, and use of sanitizing agents such as IPA during gowning.
• Ability to remove jewelry, make-up, and nail adornments when wearing cleanroom attire.
• Ability to perform physical tasks that 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 experience in microbiology related to drug substance (bulk) or drug product (fill/finish) manufacturing.

Responsibilities

• Monitor controlled environments, personnel, and clean utilities.
• Perform and analyze microbiological tests, 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 product materials.
• Perform gowning and aseptic qualifications for personnel.
• Train employees.
• Peer review data.
• Complete technical writing assignments, including SOPs, protocols, reports, trend reports, risk assessments, laboratory investigations, and change controls.
• Use strong decision-making and problem-solving skills.
• Develop and drive scientific or business-related improvement ideas.

Benefits

• Annual bonuses or other incentive plans may be offered, depending on country and role.
• Equity awards may be offered, depending on country and role.
• Pension or retirement benefits may be offered, depending on country and role.
• 401(k) company match may be offered, depending on country and role.
• Health and wellness programs may be offered, depending on country and role.
• Fitness centers may be available, depending on country and role.
• Insurance benefits may include medical, dental, vision, life, and disability insurance.
• Paid time off may be offered, depending on country and role.
• Family support benefits may be offered, depending on country and role.

What This Job Offers

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