QC Micro Analyst

1 week ago

Limerick, Limerick, Ireland Regeneron Full time

Within this role you will 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)

As a QC Micro Analyst a typical day might include, but is not limited to, the following:

  • Entering laboratory clean-rooms to collect and log samples for microbial analysis
  • Performing bioburden and endotoxin sample analysis in line with standard operating procedures (SOPs)
  • Performing 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 all work is carried out in compliance with regulatory standards, company policies, and SOPs
  • Completing test records on time and peer reviewing data from other analysts for accuracy and completeness
  • Assisting in the design and setup of the QC microbiology laboratory and selecting, implementing, and calibrating laboratory instruments
  • Participating in microbiological validations for drug substances, in-process controls, buffers, and clean utilities qualification programs
  • Assisting manufacturing personnel in identifying microbiological root causes and providing technical advice as needed
  • Participating in the transfer of methodologies 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 adherence with site procedures
  • Communicating analytical data reports clearly and concisely to management
  • Identifying and implementing lab process improvements and lean initiatives
This Role Might Be For You If:
  • You have a consistent record to work independently or as part of a team
  • You possess strong trouble-shooting and problem solving skills
  • You have strong attention to detail & excellent written and oral skills

To be considered for this opportunity you should have a BS/BA or equivalent experience in Microbiology or related field and 2+ years of validated experience, or equivalent combination of education and experience.

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.

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