Quality Control Microbiology Analyst (3rd Shift)
Regeneron Pharmaceuticals, Inc, Troy, NY, United States
Overview
Regeneron is currently looking for a Quality Control (QC) Microbiology Analyst position on a 3rd shift (Saturday to Wednesday, 10:00pm-08:30am). Regeneron manufactures biopharmaceuticals for patients worldwide, including approved therapeutic proteins and those involved in clinical studies. QC Microbiology analysts perform a variety of microbiological responsibilities including 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 regulations.
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 SOPs, protocols, reports, trend reports, risk assessments, laboratory investigations, change controls.
Environmental monitoring of controlled environments, personnel and clean utilities.
Required and Preferred Qualifications
Willingness and ability to work 3rd shift, Saturday to Wednesday, 10:00pm-08:30am. Occasional off shift/weekend work/holiday coverage may be required.
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 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.
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.
Benefits and Environment
Regeneron provides an inclusive and diverse culture with benefits including health and wellness programs, fitness centers, and stock for employees at all levels. Details vary by location. In the U.S., benefits may include health and wellness programs (medical, dental, vision, life, disability), fitness centers, 401(k) company match, family support benefits, equity awards, annual bonuses, paid time off, and paid leaves. For additional information about Regeneron benefits in the US, please visit the total rewards page. For other countries, speak to your recruiter.
Equal Opportunity and Accommodations
Regeneron is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion or belief (or lack thereof), sex, nationality, ethnicity, civil status, age, citizenship status, disability, genetic information, familial status, marital or civil partnership status, pregnancy or maternity status, gender identity, military or veteran status, or any other protected characteristic in accordance with applicable laws and regulations. Reasonable accommodations are provided to participate in the job application process. Please discuss any accommodations with us.
Additional Information
Background checks may be conducted in accordance with local law. Salary Range (hourly): $24.76 - $38.70
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Regeneron is currently looking for a Quality Control (QC) Microbiology Analyst position on a 3rd shift (Saturday to Wednesday, 10:00pm-08:30am). Regeneron manufactures biopharmaceuticals for patients worldwide, including approved therapeutic proteins and those involved in clinical studies. QC Microbiology analysts perform a variety of microbiological responsibilities including 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 regulations.
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 SOPs, protocols, reports, trend reports, risk assessments, laboratory investigations, change controls.
Environmental monitoring of controlled environments, personnel and clean utilities.
Required and Preferred Qualifications
Willingness and ability to work 3rd shift, Saturday to Wednesday, 10:00pm-08:30am. Occasional off shift/weekend work/holiday coverage may be required.
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 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.
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.
Benefits and Environment
Regeneron provides an inclusive and diverse culture with benefits including health and wellness programs, fitness centers, and stock for employees at all levels. Details vary by location. In the U.S., benefits may include health and wellness programs (medical, dental, vision, life, disability), fitness centers, 401(k) company match, family support benefits, equity awards, annual bonuses, paid time off, and paid leaves. For additional information about Regeneron benefits in the US, please visit the total rewards page. For other countries, speak to your recruiter.
Equal Opportunity and Accommodations
Regeneron is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion or belief (or lack thereof), sex, nationality, ethnicity, civil status, age, citizenship status, disability, genetic information, familial status, marital or civil partnership status, pregnancy or maternity status, gender identity, military or veteran status, or any other protected characteristic in accordance with applicable laws and regulations. Reasonable accommodations are provided to participate in the job application process. Please discuss any accommodations with us.
Additional Information
Background checks may be conducted in accordance with local law. Salary Range (hourly): $24.76 - $38.70
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