Manager, Quality Control Microbiology

About This RoleOur Manager, QC Microbiology, plays a vital role within our organization. Once you complete our training, your responsibilities will include managing all the Quality Control Microbiology Labs supporting all aspects of compounding sterile pharmaceuticals and regulatory compliance within the facility. This position will also operate within the legal and regulatory compliance, producing a quality product. Additional responsibilities include managing the Microbiology staff, coordinating roles, responsibilities, and projects. Your attention to detail and adherence to precise procedures will guarantee that our medications meet the highest standards of safety, efficacy, and quality, providing patients with the best possible care and outcomes. Turn your passion for precision and your commitment to quality into a meaningful impact on healthcare across the US.Scope:Responsible for Microbiological testing and release of commercial/marketed productsResponsible for the transfer of microbiological methods from R&D and between sitesMentor, coach, and develop the skills and capabilities of staffInvestigate, and provide thorough scientific justification for all out of specification or atypical test resultsMaintain all laboratory activities within compliance to cGMPs, and QuVa Quality proceduresInterface with contract laboratories, as a technical expert and business contactManage and report on departmental Key Performance Indicators (KPI)Provide Microbiological expertise and guidance on all relevant scientific and technical issuesResponsibilities may include:Responsible for planning and execution of routine release, stability, and investigational testing for sterility and endotoxinsPrepare, review, and approve departmental SOPsMaintain accurate records, in compliance with cGMP and QuVa documentation policiesImplement continuous improvement initiatives, including new instrumentation or methods, to enhance throughput, efficiency, and compliance in the laboratoryProvide scientifically sound investigations of OOS resultsProvide Quality and Compliance oversite within the microbiology laboratoriesEffectively communicate with, and support Quality and Operations functionsManage laboratory budgetsResponsible for implementation and maintenance of the laboratory safety programOther duties as assignedQualifications:Legally authorized to work in the job posting countryB.S. or M.S. degree in Microbiology or related field required5 years prior experience in Quality Assurance /Laboratory/ cGMP / FDA regulated industry3 years of supervisory or management experience requiredExperience in sterile manufacturing preferredExperience and expertise in USP <71> Sterility Testing, with an emphasis in Scan RDI instrumentation and methods, including method development and validationExpertise with USP <85> Endotoxin testing, including interpretation of results, investigation, and troubleshootingThorough understanding of 21CFR Part 211 cGMP requirements for sterile drug products with emphasis on 2004 Guidance for Sterile Drug Products produced by Aseptic ProcessingBenefits of Working at Quva:Set, full-time, consistent work scheduleComprehensive health and wellness benefits including medical, dental and vision401k retirement program with company match22 paid days off plus 8 paid holidays per yearOccasional weekend and overtime opportunities with advance noticeNational, industry-leading high growth company with future career advancement opportunitiesThe base compensation for this role is estimated to be within the range described below. The compensation offered may vary depending on relevant factors such as experience, skills, training, education, certifications, geographic location, and market conditionsRange: $117,000 - $136,000 AnnuallyThis role is also eligible for an annual incentive bonus, subject to program terms and guidelinesAbout Quva:Quva provides industry-leading health-system pharmacy services and solutions, including 503B sterile injectable outsourcing services and AI-based data software solutions that help power the business of pharmacy. Quva Pharma’s multiple production facilities and industry-first dedicated remote distribution capabilities provide ready-to-administer sterile injectable medicines critical to patient care. Quva BrightStream partners with health systems to aggregate, normalize, and analyze large amounts of complex data across their sites of care, and through proprietary machine learning, transforms data into actionable insights supporting revenue optimization, script capture, inventory management, drug shortage control, and more. Quva’s overall progressive and integrated platform helps health-systems transform pharmacy management to achieve greater value and deliver highest-quality patient care.Job SummaryRequisition Number: MANAG006099Job Category: 8000-QualitySchedule: Full-Time