As a QC Micro Analyst you will perform testing to ensure cGMP compliance in the manufacturing facility. You will be responsible for assessing the microbiological quality of products, manufacturing equipment, manufacturing process areas, and facility utilities.
This is 12/7 shift role.
As a QC Micro Analyst a typical day might include, but is not limited to, the following:
- Enter a Laboratory Cleanroom to collect and log samples for microbial analysis.
- Perform bioburden and endotoxin sample analysis in accordance with standard operating procedures (SOPs).
- Perform or support the sample analysis for microbial identification.
- Perform environmental monitoring including surface, settling and viable and non-viable particulate air monitoring of aseptic operations and controlled areas.
- Perform acceptance testing of commercially prepared microbiological culture media.
- Autoclave microbiological media and laboratory waste as needed.
- Ensure that all work carried out is in compliance with the required regulatory standards, conform to company policies and standard operating procedures (SOPs).
- Complete own test records on time and peer review data from other analysts for accuracy and completeness.
- Assist in the design and set-up of the QC microbiology laboratory and selection/ implementation and calibration of laboratory instruments.
- Participate in microbiological validations as needed for drug substance, in-process controls, buffers and clean utilities qualification program.
- Conduct laboratory investigations and generate reports in response to invalid assays, Deviations, OOS/OOT.
- Initiate and complete CAPAs and Change Controls in accordance with site procedures.
- Write new and update current SOPs as needed.
- Perform other duties relevant to the QC laboratory position as required.
To be considered for this opportunity you should have a BS/BA in Life Sciences or equivalent. Or equivalent combination of education and experience.
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 comprehensive benefits including health and wellness programs, fitness centers and 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. 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.
The salary ranges provided are shown in accordance with U.S. law and apply to U.S. based positions, where the hired candidate will be located in the U.S. If you are outside the U.S, please speak with your recruiter about salaries and benefits in your location.