Quality Control Micro Analyst- Compliance

Location
Rensselaer, New York, United States of America
Posted
Jun 06, 2021
Ref
23834BR
Required Education
Bachelors Degree
Position Type
Full time
Regeneron is currently looking for a Quality Control (QC) Microbiology Analyst with a primary focus on compliance and review of data with a 1st shift, Monday-Friday, 8am-4:30pm 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 team 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.

As a QC Micro Analyst, a typical day might include the following:
• High involvement in laboratory investigations.
• Performing deviation investigations, reviewing data and supporting procedural updates as required.
• 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.
• 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:
• Have previous experience in a GMP laboratory setting.
• 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.
• 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.

To be considered for the QC Micro Analyst position you must be willing and able to work 1st shift, Monday-Friday, 8am-4:30pm.
Associate QC Micro Analyst: BS/BA in Life Sciences, or related field, or an equivalent combination of education and experience
QC Micro Analyst: BS/BA in Life Sciences, or related field, and a minimum of 12-18+ months of related experience; or an equivalent combination of education and experience
Sr. QC Micro Analyst I: BS/BA in Life Sciences, or related field, and 4+ years of experience; or an equivalent combination of education and experience
Sr. QC Micro Analyst II: BS/BA in Life Sciences, or related field, and 6+ years of experience; or an equivalent combination of education and experience
Prior GMP experience in Microbiology related to drug substance or drug product manufacturing is preferred. Level is determined based on qualifications relevant to the role.

Does this sound like you? Apply now to take your first steps toward living the Regeneron Way! We have an inclusive and diverse culture that provides amazing benefits including health and wellness programs, fitness centers and stock for 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 maternity status, gender identity, gender reassignment, military or veteran status, or any other protected characteristic in accordance with applicable laws and regulations. We will ensure that individuals with disabilities are provided reasonable accommodations to participate in the job application process. Please contact us to discuss any accommodations you think you may need.

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