QC Micro Analyst

3 weeks ago

Dublin, Dublin City, Ireland Regeneron Pharmaceuticals, Inc Full time

As a QC Micro Analyst you would perform testing to ensure cGMP compliance in the manufacturing facility. Responsible for assessing the microbiological quality of products, manufacturing equipment, manufacturing process areas, and facility utilities.

Note, this is a shift based role (12/7 - extended days)

In this role a typical day might include, but is not limited to, the following:

  • Entering a Laboratory Cleanroom to collect and log samples for microbial analysis
  • Performing bioburden and endotoxin sample analysis in accordance with standard operating procedures (SOPs)
  • Performing or supporting the sample analysis for microbial identification
  • Performing environmental monitoring including surface, settling and viable and non-viable particulate air monitoring of aseptic operations and controlled areas
  • Performing acceptance testing of commercially prepared microbiological culture media
  • Autoclaving microbiological media and laboratory waste as needed
  • Ensuring that all work carried out is in compliance with the required regulatory standards, conforming to company policies and standard operating procedures (SOPs)
  • Completing own test records on time and peer reviews data from other analysts for accuracy and completeness
  • Assisting in the design and set-up of the QC microbiology laboratory and selection/ implementation and calibration of laboratory instruments
  • Participating in microbiological validations as needed for drug substance, in-process controls, buffers and clean utilities qualification program
  • Assisting manufacturing personnel in the identification of microbiological root cause analysis and provide technical advice as needed
  • Participating in the transfer of methodology from other test facilities
  • Maintaining laboratory reagents, media and supplies
  • Conducting laboratory investigations and generating reports in response to invalid assays, Deviations, OOS/OOT
  • Initiating and completing CAPAs and Change Controls in accordance with site procedures
  • Writing new and updates current SOPs as needed
  • Providing training to other analysts in the QC group
  • Performing 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 along with relative experience (preferably in the pharmaceutical or biotechnology industries ). Will substitute relevant work experience in lieu of degree requirement.

#IRELIM #JOBSIEST

Does this sound like you? Apply now to take your first step towards living the Regeneron Way We have an inclusive and diverse culture that provides comprehensive benefits, which often include (depending on location) health and wellness programs, fitness centers, 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. The Company will also provide reasonable accommodation to the known disabilities or chronic illnesses of an otherwise qualified applicant for employment, unless the accommodation would impose undue hardship on the operation of the Company's business.

For roles in which the hired candidate will be working in the U.S., the salary ranges provided are shown in accordance with U.S. law and apply to U.S.-based positions. For roles which will be based in Japan and/or Canada, the salary ranges are shown in accordance with the applicable local law and currency. If you are outside the U.S, Japan or Canada, please speak with your recruiter about salaries and benefits in your location.

Please note that certain background checks will form part of the recruitment process. Background checks will be conducted in accordance with the law of the country where the position is based, including the type of background checks conducted. The purpose of carrying out such checks is for Regeneron to verify certain information regarding a candidate prior to the commencement of employment such as identity, right to work, educational qualifications etc.

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