Quality Control Analyst III

MPI does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity or expression, national origin, age, disability, veteran status, marital status, or based on an individual''s status in any group or class protected by applicable federal, state or local law. MPI encourages applications from minorities, women, the disabled, protected veterans and all other qualified applicants.SummaryThe Quality Control Analyst plays a vital role in the environmental monitoring of clinical manufacturing aseptic processes, sterility and lot release testing, and purified water testing while also preparing the Quality Control processes for commercial launch. Client DetailsOur client is a top privately held biotech company with an innovative technology platform focused on the treatment of retinal diseases.DescriptionPerform routine environmental monitoring of the ISO-5, ISO-7, and ISO-8 clean room suites during aseptic processing activities:Non-viable airborne particulate countsViable airborne particulate monitoringViable surface monitoringPersonnel monitoringPerform growth promotion, sterility, and pH testing of all microbial growth media lotsPerform sterility testing of drug substance and finished drug productPerform TOC and conductivity testing of potable and purified water samplesPerform microbial testing (Standard Methods Agar culture and Colilert) of potable and purified water samplesPerform endotoxin testing on finished drug product and clean steam samples; qualify new lots of CSE standard, lysate, and cartridgesPerform Gram stain, as necessary, for preliminary identification of microbial isolatesFollow standard operating procedures Good documentation skills, maintain laboratory notebooks, and attention to detailSchedule preventive maintenance and calibration of equipment and troubleshooting, as necessaryMaintain reagent and laboratory suppliesReview documents and laboratory test results; interpret and summarize resultsInitiate and revise SOPs; Perform studies according to protocolsGenerate period environment tal monitoring summary reportsAnalyze data and write summary reports, as neededProfileMust have a bachelor''s degree in a related science (biology, microbiology, biochemistry, etc.)Must have 5 - 8 years experience in a cGMP laboratory and cleanroom environment, experience in Quality Control preferredMust be proficient in basic laboratory and cleanroom aseptic techniques, good documentation skills, and maintain and clean and safe work environment following company safety proceduresExperienced in performing microbiology testing procedures, TOC/conductivity, sterility, environmental monitoring of clean rooms, and basic troubleshootingMust havecGMP/GLP experience with the ability to interpret and apply USP methods and FDA guidanceCandidate needs to be highly motivated and flexible, with the ability to effectively communicate and to work independently day to day and collaboratively on project teamStrong oral and written communication skills with experience in writing SOPs and technical reportsMust be proficient in Microsoft Office (Word, Outlook, Excel, PowerPoint)Must be detail oriented with good organizational and planning skillsMust be reliable and possess a positive attitude, willingness to learn and perform hands-on daily operationsJob OfferCompetitive base salary and benefit packageOpportunity for career growth and developmentJoin rapidly growing QC function at a clinical stage Biotech company

Created: 2021-11-29