QC Micro Analyst

2 weeks ago


Rensselaer, United States Regeneron Pharmaceuticals, Inc Full time
Regeneron is currently looking for a Quality Control (QC) Microbiology Analyst focusing on fill finish activities with a 1st shift, Sunday- Thursday, 7am-3:30pm schedule. Regeneron successfully manufactures a range of biopharmaceuticals for patients worldwide, including our approved therapeutic proteins and those involved in clinical studies. 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 aseptic fill/finish manufacturing areas, utilities sampling and testing, , gowning and aseptic qualifications, and raw materials, in process and finished product testing related to drug manufacturing.

As a QC Micro Analyst, a typical day might include the following:

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.

This role might be for you if:

Enjoy working in a fast-paced environment and you have the innate ability to balance multiple priorities and/or prioritize and execute them. Can take on new and sometimes ambiguous challenges and learn quickly. Are able to work in a team environment and demonstrate respectful behavior at all times to promote and encourage a learning environment. 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.

Shift Requirements: Physical

Ability to perform physical requirements for entirety of shift (up to 10 hours):

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

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

To be considered for the QC Micro Analyst you must be willing and able to work Sunday- Thursday, 7am-3:30pm. You must have a BS/BA in Life Sciences, or related field; or an equivalent combination of education and experience. For the various levels you must have the following:

Associate QC Micro Analyst: 0-12+ months of experience

QC Micro Analyst: 12-18+ months of experience

Sr. Micro QC Analyst I: 4+ years of experience

Prior GMP experience in Microbiology related to drug substance (bulk) manufacturing is preferred. Level is determined based on qualifications relevant to the role.

#LI-MB1


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