Quality Control Analyst (Microbiology)

Regulatory Jobs; City of Rensselaer (NY); Presencial; USD 34.000 - 53.000; Jornada completa

Descripción de la vacante

Regeneron seeks a QC Microbiology Analyst to perform environmental monitoring and microbiological testing across drug substance and product areas. You will handle gowning qualifications, data peer review, and technical writing for SOPs, reports, and investigations, contributing to GMP compliance on a 2nd shift basis in Rensselaer, NY.

Responsibilities include rapid data analysis, collaboration with operations, and training teammates, with a focus on accuracy, safety, and adherence to SOPs and

Formación

• BS/BA in Microbiology, Biology, or related field.
• 12–18+ months of related GMP microbiology experience preferred.
• Experience with environmental monitoring and drug substance/product testing preferred.

Responsabilidades

• Environmental monitoring of controlled environments, personnel and clean utilities.
• Microbiological testing and analysis on diverse sample types (environmental, materials, in-process, final products).
• Gowning and aseptic qualifications for personnel.
• Training of employees.
• Peer review of data.
• Technical writing: SOPs, protocols, reports, trend reports, risk assessments, investigations.

Conocimientos

Environmental monitoring

Microbiology testing

Gowning aseptic tech

Training & data review

Technical writing

MS Excel

LIMS familiarity

Educación

BS/BA in Microbiology or related field

Herramientas

LIMS

Deviation Management

Learning Management Systems

Microsoft Word

Excel

PowerPoint

Descripción del empleo

Regeneron successfully manufactures a range of biopharmaceuticals for patients worldwide. We are lookingto fill aQuality Control (QC) Microbiology Analyst position. Our Microbiology Analysts 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 regulation. This position will be primarily responsible for performing routine environmental monitoring for drug substance/drug product manufacturing areas, utilities sampling and testing, gowning and aseptic qualifications, and raw materials, in process and finished product testing related to drug manufacturing.

When & where:

• Sunday-Wednesday, 2nd shift 1:00pm - 11:30pm
• Location: Rensselaer, New York, United States

Discover your role:

• Environmental monitoring of controlled environments, personnel and clean utilities.
• Microbiological testing and analysis (bioburden testing, endotoxin content testing, plate enumeration, growth promotion, etc.) on a variety of sample types, related to environmental monitoring, utility, raw materials, and in-process and final product materials.
• 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, change controls, etc.

• Have strong decision making and problem-solving skills.

• Develop and drive scientific and/or business-related improvement ideas.
• Have working knowledge of Microsoft Suite applications (Word, Excel, Powerpoint), Laboratory Information Management System (LIMS), Deviation Management Systems, and Learning Management Systems.

This role requires:

A BS/BA in Microbiology, Biology, or a related field, and a 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.
• Level is determined based on experience and qualifications relevant to the role.

Gowning and Environment:

• Full cleanroom attire (Examples may include: including laundered undergarments, gown, facemask, hairnet, safety glasses, safety shoes and booties, latex gloves and the use of sanitizing agents during gowning process including IPA)
• Ability to remove jewelry, make-up and nail adornments when wearing cleanroom attire

Shift & Physical Requirements:

• Ability to perform physical requirements for entirety of shift (up to 10 hours) in a clean room environment
• Some physical requirements can include but not limited to: bending, climbing, crawling, kneeling, reaching, reaching overhead, sitting, squatting, walking, standing, driving, hand manipulation and ability to lift/push/pull up to 50lbs

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. Please speak with your recruiter and hiring manager for more information about on-site expectations for your role and location.

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 (hourly)

$24.76 - $38.70