Job Description
**Job Summary:** Lead Micro QC Analyst responsible for ensuring cGMP compliance in manufacturing facility, assessing microbiological quality of products and equipment, and providing guidance and support to employees. **Job Description:** 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. **Key Responsibilities:** * Assess microbiological quality of products, manufacturing equipment, manufacturing process areas, and facility utilities * Provide on-the-floor guidance and support to employees * Ensure employees' timesheets are completed on time * Monitor employees' training to ensure all requirements are met * Maintain up-to-date training records for self and direct reports * Perform monthly performance feedback meetings with direct reports * Escalate all performance issues to management and/or HR **Daily Activities:** * Provide microbiology representation and participation in cross-functional site meetings * Administer programs such as gowning, training, ordering and calibration * Conduct technical writing assignments such as SOPs, protocols, final reports, trend reports, risk assessments, laboratory investigations, etc * Train other new employees and prioritize workloads on a daily basis * Review peer data * Investigate laboratory reports * Identify microbial procedures * Maintain laboratory supplies, media, and reagents inventory * Participate in the overtime and weekend schedule as required * Test bioburden and endotoxin of products and raw materials * Test microbiological of in-process and final product materials * Test biological and endotoxin indicators used in the validation of manufacturing equipment * Update microbiological environmental monitoring results database and prepare monthly reports * Test for acceptance of commercially prepared microbiological culture media * Coordinate equipment maintenance and calibration * Utilize Laboratory Information Management System (LIMS) for sample and sample test result tracking * Perform all duties relevant to the Quality Control Microbiology Analyst position as required **Requirements:** * BS/BA in Microbiology or related field * 1+ years of relevant experience or equivalent combination of education and experience * Proven ability to work independently or as part of a team * Strong trouble-shooting and problem solving skills * Strong attention to detail & excellent written and oral skills **About Regeneron:** 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.