Quality Control Microbiology Analyst (3rd Shift)

Regeneron PharmaceuticalsRensselaer, IN
Onsite

About The Position

Regeneron is currently looking for a Quality Control (QC) Microbiology Analyst position working a 3rd shift, Saturday to Wednesday, 10:00pm-08:30am. Regeneron successfully manufactures a range of biopharmaceuticals for patients worldwide, including our approved therapeutic proteins and those involved in clinical studies. Quality Control Microbiology analysts perform a variety of microbiological responsibilities including but not limited, to clean room and utility monitoring as well as raw material, in-process, and product testing in accordance with Standard Operating Procedures (SOPs) and cGMP/FDA regulation.

Requirements

  • Working knowledge of Microsoft Suite (Word, Excel, Powerpoint), Laboratory Information Management System (LIMS), Deviation Management Systems, and Learning Management Systems.
  • Must be willing and able to work 3rd shift, Saturday to Wednesday, 10:00pm-08:30am.
  • Associate QC Analyst: BS/BA in Life Sciences, or related field, or an equivalent combination of education and experience
  • QC 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 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 Analyst II: BS/BA in Life Sciences, or related field, and 6+ years of experience; Or an equivalent combination of education and experience

Nice To Haves

  • Prior GMP experience in Microbiology related to drug substance or drug product manufacturing is preferred.

Responsibilities

  • Microbiological testing and analysis (bioburden testing, endotoxin content testing, plate enumeration, growth promotion, etc.) on a variety of sample types.
  • Training of employees.
  • Peer review of data.
  • Maintaining laboratory supplies, media, and reagents.
  • Performing biological indicator testing used in the validation of manufacturing equipment.
  • Technical writing assignments including but not limited to SOPs, protocols, reports, trend reports, risk assessments, laboratory investigations, change controls.
  • Environmental monitoring of controlled environments, personnel and clean utilities.

Benefits

  • health and wellness programs
  • fitness centers
  • stock for employees at all levels
  • medical, dental, vision, life, and disability insurance
  • 401(k) company match
  • family support benefits
  • equity awards
  • annual bonuses
  • paid time off
  • paid leaves (e.g., military and parental leave)
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