Within this role 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.
Lead-Related Activities include, but are not limited to, the following: Providing on-the-floor guidance and support to employees Ensuring employees' timesheets are completed on time Monitoring employees' training to ensure that all requirements, including OJT, are met Maintaining up-to-date training records for self and direct reports Performing monthly performance feedback meetings with direct reports Escalating all performance issues to management and/or HR As a Lead Micro QC Analyst, a typical day might include, but is not limited to, the following: Providing microbiology representation and participation in cross-functional site meetings Administering programs such as gowning, training, ordering and calibration Conducting technical writing assignments such as SOPs, protocols, final reports, trend reports, risk assessments, laboratory investigations, etc Training other new employees and prioritizing workloads on a daily basis Reviewing peer data Investigating laboratory reports Identifying microbial procedures Maintaining laboratory supplies, media, and reagents inventory Participating in the overtime and weekend schedule as required Testing bioburden and endotoxin of products and raw materials Testing microbiological of in-process and final product materials Testing biological and endotoxin indicators used in the validation of manufacturing equipment Updating microbiological environmental monitoring results database and preparing monthly reports Testing for acceptance of commercially prepared microbiological culture media Coordinating equipment maintenance and calibration Utilizing Laboratory Information Management System (LIMS) for sample and sample test result tracking Performing all duties relevant to the Quality Control Microbiology Analyst position as required This role might be for you if: You have a proven ability 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 in Microbiology or related field and 1+ years of relevant experience or equivalent combination of education and experience.
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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. 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.