Quality Control Analyst

Job Title -QC AnalystLocation - Winchester KY 40391Duration - 3+ months contract to hire positionShift Time - SAT, SUN, MON 6AM - 6PM AND BIWEEKLY TUES 6AM - 2:30PMRole Description:"Client is a growing Biotech Contract Development and Manufacturing Organization (CDMO) with an internationally recognized tradition of quality and service. Paragon Bioservices provides process development and GMP manufacturing services for Phase I/II clinical trials to industry leaders as well as innovative start-ups utilizing novel technologies to produce state-of-the-art vaccines and therapies for people when they are most in need. As a Paragon employee, you will actively contribute to the delivery of our services and products to our customers and their patients.This role is responsible for Environmental Monitoring sampling, analyzing, and aseptic monitoring and microbiological testing to support Phase I/II GMP manufacturing. Works in a fast-paced environmental supporting the quality control department of a CMO for manufacturing of biologic bulk drug substance, sterile finished drug product, and fill/finish.Job Roles and responsibilitiesPrimary responsibility is in Environmental Monitoring in classified cleanrooms. Monitoring of surfaces, air, and non-viable air quality of ISO 5, 7, and 8 cleanrooms.Conducts testing of utilities such as USP water, clean steam, and testing of other manufacturing environments (air, surfaces)Builds credibility within the lab group by performing high quality workWorks closely with manufacturing and QA to coordinate routine EM, changeover EM, and monitoring to support client campaignsPerforms media fills and fill/finish monitoring which includes continuous monitoring of air quality, personnel aseptic technique, and environment integrityActs as Quality Control authority for aseptic flow and behavior within cleanroomsUtilizes MODA to enter, compile, and trend environmental data for reporting purposesWorks closely with Manufacturing and Quality Assurance staff to resolve quality issues with regard to the facilityEffectively communicates results of own work through discussions and documentation with some input from supervisorFlexibility in following unique campaign requirements that may include off-hour and weekend workMay conduct bioburden and membrane filtration testing on cleaning, in-process and release samples.Minimum Qualifications & ExperienceAssociates degree in a Life Sciences discipline and 2 years of relevant experience working in cGMP cleanroomsExperience working in cGMP Quality ControlExperience with Microsoft Excel and Microsoft WordStrong attention to detailFamiliarity with Good Manufacturing Practices (cGMP's)Have the knowledge and ability to apply basic scientific and regulatory principles utilized to solve operational, as well as routine quality tasksMust be able to work off hours or weekends as requiredLIMS or MODA experience a plusExperience conducting bioburden and membrane filtration testing a plusCompany Overview:Infojini Consulting is a Staffing and Recruitment company and incorporated in Baltimore, MD.Infojini caters various hospitals, health & wellness centers, pharmacy, and medical facilities over fifty states across the United States

Created: 2025-03-08