Job Summary Cellipont Bioservices is growing, and we are looking for a QC Lead Analyst, Microbiology, who believe in the potential bridging client's discoveries to patient cures and who want to challenge the status quo and take Cellipont and its clients to the next level. The QC Lead Analyst, Microbiology is responsible for Environmental Monitoring sampling, analyzing, and reporting results, and microbiological testing to support 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.The QC Lead Analyst, Microbiology applies microbiological principles to evaluate contamination risk in aseptic manufacturing, provides scientific input to cross-functional teams, and ensures laboratory testing is executed accurately, on time and in compliance with cGMP. This role will also require the individual to demonstrate a strong ability to work cross-functionally and possess strong leadership skills. The Role Own, execute, and finalize Environmental Monitoring Performance Qualifications of cleanroomsIdentify objectionable microorganisms and impact to production activitiesImplement EU Annex 1 updates to the QC procedures and EM Programs/Policies. Cross-train into other Quality Control testing areas as requiredCompile, trend and interpret large sets of Environmental Monitoring data and prepare technical reports.Perform routine Environmental Monitoring of Grade A-D Cleanroom environment, including sampling of viable surfaces, viable air and non-viable particulates in a GMP Manufacturing facilityProvides input on SOP revisions and assist in the creation and editing of protocols, risk assessment etc. Works closely with manufacturing and QA to coordinate routine EM, changeover EM, and monitoring to support client campaignsPerforms Aseptic Process Simulations (media fills) and fill/finish monitoring which includes continuous monitoring of air quality, personnel aseptic technique, and environment integrityPerform Gown Qualifications and BSC QualificationsReport and evaluate environmental monitoring excursions and OOS results, applying microbiological principles to support investigations and root-cause assessmentReport and investigate environmental monitoring excursions and OOS results Effectively 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 workAbility to train fellow analysts on Environmental Monitoring and other microbiological assays Lead and own various Environmental Monitoring and other QC projects on an as needed basis in collaboration with other departmentsAssist in inventory management and cost effectiveness for the department Other duties as assignedThe CandidateBachelor's degree (B.S.) in Biology, Microbiology, Biotechnology or a closely related biological science is required, with 4–5 years of relevant industry experienceHave the knowledge and ability to apply basic scientific and regulatory principles utilized to solve operational, as well as routine quality tasksKnowledge and ability to apply biological, microbiological and regulatory principles to solve scientific and quality problemsSelf-starter with the ability to produce results in a fast-paced environment to meet client deadlines under minimal supervisionExperience with viable and non-viable Environment Monitoring collection instrumentsCreative individual with outstanding trouble shooting skills Concentration of aseptic technique and contamination controlStreak plating and microbial identificationDocument writing, data interpretation, presentation, statistical analysis and trending a plusMinimum supervision required on day-to-day activities and accomplished tasksEscalates problems and factors impacting work performance or completion of assigned tasks to the area supervisorExperience working in cGMP Quality Control LaboratoryExperience with Microsoft OfficeStrong attention to detailFamiliarity with Good Manufacturing Practices (cGMP's)Excellent oral and written communication skills. Must be available to work occasional weekend or holiday support as neededPosition BenefitsOpportunities for career growth within an expanding teamDefined career path and annual performance review & feedback processCross-functional exposure to other areas of within the organization Robust benefit package designed for unique Health & Wellness needs, including coverage for your furry family members401K strong employer match Tuition ReimbursementEmployee Referral BonusesFlexible work schedules and PTO and paid holidaysGain experience in the cutting-edge cell therapy space "At Cellipont Bioservices, we look for candidates with an innate desire to serve. Our "family" approach ensures you will get the mentorship you need to develop a satisfying career here!" Notice to Agency and Search Firm RepresentativesCellipont Bioservices is not accepting unsolicited resumes from agencies and/or search firms for this job posting. Resumes submitted to any Cellipont Bioservices employee by a third-party agency and/or search firm without a valid written & signed search agreement will become the sole property of Cellipont Bioservices. No fee will be paid if a candidate is hired for this position because of an unsolicited agency or search firm referral. Thank you.