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Lead QC Micro Analyst

Company: Regeneron Pharmaceuticals
Location: Aurora
Posted on: January 15, 2022

Job Description:

Company OverviewRegeneron is a leading biotechnology company that invents life-transforming medicines for people with serious diseases. Founded and led for over 30 years by physician-scientists, our outstanding ability to repeatedly and consistently translate science into medicine has led to nine FDA-approved treatments and numerous product candidates in development, all of which were homegrown in our laboratories. Our medicines and pipeline are designed to help patients with eye disease, allergic and inflammatory diseases, cancer, cardiovascular and metabolic diseases, infectious diseases, pain and rare diseases. Our mission is to use the power of science to bring new medicines to our patients.Summary: - Performs 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.Lead-Related Activities include, but are not limited to, the following:Provides on-the-floor guidance and support to employees.Ensures employees timesheets are completed on time.Monitors employees training to ensure that all requirements are met, including OJT.Maintain up to date training records for self and direct reports.Perform monthly performance feedback meetings with direct reports.Escalates all performance issues to management and/or HR.Essential Duties and Responsibilities include, but are not limited to, the following:Microbiology representation and participation in cross functional site meetings.Administration of programs such as gowning, training, ordering, calibration, etc.Technical writing assignments such as SOPs, protocols, final reports, trend reports, risk assessments, laboratory investigations, etc.Participates in training of other new employees and prioritizes workloads on a daily basis.Performs peer review of data.Performs laboratory investigation reports.Performs microbial identification procedures.Maintains laboratory supplies, media, and reagents inventory.Participates in the overtime and weekend schedule as required.Performs bioburden and endotoxin testing of products and raw materials.Performs microbiological testing of in-process and final product materials.Performs biological and endotoxin indicator testing used in the validation of manufacturing equipment.Updates microbiological environmental monitoring results database and prepares monthly report.Performs acceptance testing of commercially prepared microbiological culture media. -Assists in coordinating equipment maintenance and calibration.Uses Laboratory Information Management System -(LIMS) for sample and sample test result tracking.Performs all duties relevant to the Quality Control Microbiology Analyst position as required.Education and Experience:Requires BS/BA in Microbiology or related field and 1+ years of relevant experience.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 amazing benefits including health and wellness programs, fitness centers and stock for employees at all levels!Regeneron is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, colour, religion or belief (or lack thereof), sex, nationality, national or ethnic origin, civil status, age, citizenship status, membership of the Traveller community, sexual orientation, disability, genetic information, familial status, marital or registered civil partnership status, pregnancy or maternity 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. -Job SummaryJob number: R6296Date posted : 2021-11-23Profession: General and AdministrativeEmployment type: Full time

Keywords: Regeneron Pharmaceuticals, Aurora , Lead QC Micro Analyst, Professions , Aurora, Colorado

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