Quality Control, Scientist

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 will play a vital role on the team working in environmental monitoring and aseptic processing. Client DetailsA small, fast growing, Biotech Company delivering therapeutics for the treatment of eye related 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 environmental 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 proceduresStrong oral and written communication skills with experience in writing SOPs and technical reportsJob OfferCompetitive base salary and benefit packageOpportunity for growth and developmentJoin a innovated and focused biotech company

Created: 2021-11-29