Quality Control Micro Analyst- Fill Finish (1st shift)

Rensselaer, New York
May 21, 2022
Quality, Quality Control
Required Education
Bachelors Degree
Position Type
Full time

Regeneron is currently looking for a Quality Control (QC) Microbiology Analyst with a 1st shift, Sunday-Thursday, 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 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, utilities sampling and testing, and raw materials, in process and finished product testing related to drug substance/product manufacturing. This position is slated to support our Fill Finish utilities and HVAC qualification activities.

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.
  • 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.

To be considered for the QC Micro Analyst position you must be willing and able to work Sunday-Thursday, 8am-4:30pm. For the various levels you must have the following:

Associate QC Micro Analyst: BS/BA in Life Sciences, or related field; Or 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 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 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 equivalent combination of education and experience

Prior GMP experience in Microbiology related to drug substance (bulk) or drug product (fill/finish) 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.