QC Micro Analyst- Compliance at Regeneron Pharmaceuticals, Inc.

Regeneron is currently looking for a Quality Control (QC) Microbiology Analyst position with a primary focus on compliance and review of data within the Quality Control Microbiological laboratory with a 1st shift, Monday-Friday, 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 Operations group performs microbiological and environmental monitoring 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 responsible for performing deviation investigations, review data, and supporting procedural updates as required.

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

• High involvement in laboratory investigations.
• Ownership and implementation of changes identified through deviation investigations.
• Working cross-functionally with other departments to support deviation investigations and implementation of procedural updates or other changes.
• Technical writing assignments such as SOPs, protocols, reports, trend reports, risk assessments, laboratory investigations, CAPAs, Change Controls, etc.
• Peer review of data.
• Bioburden and endotoxin testing of utility, products and raw materials.
• Microbiological testing and analysis on a variety of sample types, related to environmental monitoring, utility, raw materials, and in-process and final product materials.
• Environmental monitoring of controlled environments, and clean utilities.

This role might be for you if:

• Enjoy working in a fast-paced environment and you have the innate ability to balance multiple priorities, prioritize them 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 (Word, Excel, Powerpoint), 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 position you must be willing and able to work 1st shift, Monday-Friday, 7am-3:30pm. You must have a BS/BA in Life Sciences, or related field and 2+ years of experience; or an equivalent combination of education and experience.

Prior GMP experience in Microbiology related to drug substance or drug product manufacturing. Level is determined based on qualifications relevant to the role.

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Does this sound like you? Apply now to take your first step towards living the Regeneron Way! We have an inclusive and diverse culture that provides comprehensive benefits, which often include (depending on location) health and wellness programs, fitness centers, equity awards, annual bonuses, and paid time off for eligible employees at all levels!

Regeneron is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion or belief (or lack thereof), sex, nationality, national or ethnic origin, civil status, age, citizenship status, membership of the Traveler community, sexual orientation, disability, genetic information, familial status, marital or registered civil partnership status, pregnancy or parental status, gender identity, gender reassignment, military or veteran status, or any other protected characteristic in accordance with applicable laws and regulations. The Company will also provide reasonable accommodation to the known disabilities or chronic illnesses of an otherwise qualified applicant for employment, unless the accommodation would impose undue hardship on the operation of the Company's business.

For roles in which the hired candidate will be working in the U.S., the salary ranges provided are shown in accordance with U.S. law and apply to U.S.-based positions. For roles which will be based in Japan and/or Canada, the salary ranges are shown in accordance with the applicable local law and currency. If you are outside the U.S, Japan or Canada, please speak with your recruiter about salaries and benefits in your location.

Please note that certain background checks will form part of the recruitment process. Background checks will be conducted in accordance with the law of the country where the position is based, including the type of background checks conducted. The purpose of carrying out such checks is for Regeneron to verify certain information regarding a candidate prior to the commencement of employment such as identity, right to work, educational qualifications etc.

Salary Range (hourly)