Microbiology Quality Control Analyst II - Pharmaceutical Quality Assurance
DescriptionAs a Microbiology Quality Control Analyst, you will be an integral part of the Microbiology Laboratory and Environmental Monitoring (EM) Program. This position is dedicated to various microbial testing, EM monitoring of aseptic production areas, ordering and stocking supplies, as well as creating and reviewing Standard Operating Procedures (SOPs). You will also be responsible for investigation writing and data entry related to microbiological assessments.ResponsibilitiesOversee day-to-day operations, testing, and EM monitoring for the Micro team within the Quality Assurance Department.Conduct microbial testing and monitor aseptic production areas to ensure compliance with quality standards.Engage in data entry of EM sampling results, LIMS, logbooks, and miscellaneous lab data.Participate in interactions with Project Teams and cross-functional groups related to site operations.RequirementsPrevious experience in quality control microbiology is essential.Preferred experience in bioburden testing, membrane filtration, sterility isolator testing, conductivity, total organic carbon, or endotoxin assays.Basic knowledge of aseptic manufacturing environmental monitoring within Grade A-D areas.Experience in SOP review, creation, and approval is preferred.Familiarity with OOS investigations writing is advantageous.Understanding of compliance with all cGMP standards, safety, environmental regulations, and company SOPs.Work ScheduleThe Position Offers Two Potential ShiftsMonday - Friday from 7:00 am to 3:30 pmMonday - Friday from 10:00 am to 6:30 pmSome flexibility in start and end times may be allowed, with occasional weekend work and overtime as required.Employment Type: Contractor