Environmental Compliance Supervisor 2nd Shift

Our Work MattersAt Kindeva we make products that save lives ensuring better health and well-being for patients around the Impact You Will MakeThis Environmental Compliance (EC) Supervisor role will serve the Brentwood MO location as part of second (2nd) shift operations with hours from 1400 - 2230 Monday through Friday. Occasional weekend or off shift work may be required to meet departmental and production EC Supervisor position is responsible for leading a team of environmental monitoring technicians that support 24/7 manufacturing operations. This role provides expertise and oversite for environmental monitoring (EM) and utility monitoring programs EM excursion investigations contamination control inspection readiness and quality systems within a fast-paced CDMO biopharmaceutical manufacturing ResponsibilitiesThis role will collaborate with other EC supervisors to ensure timely completion of all daily weekly and monthly sampling along with the associated documentation review. They will assist in investigations EM oversight equipment troubleshooting CAPA actions and change controls and regulatory inspection readiness. Additionally this role will collaborate with manufacturing colleagues and leadership to ensure clear communication regarding production needs monitoring needs and any ad hoc sampling that needs to be OversightServe as an SME for environmental monitoring contamination control and environmental monitoring continuous improvement initiatives to strengthen QC quality systems compliance and operational as a technical advisor to QC leadership for quality compliance and technical Review and Data IntegrityPerform and/or oversee review of EM data packets and MODA samples as compliance withcGMP requirementsData integrity requirementsALCOA principlesGood Documentation Practices (GDP)Evaluate raw data electronic records audit trails and laboratory documentation as data integrity remediation activities and risk and Digital Quality SystemsManage daily weekly monthly sample plans and ensure proper completion within the MODA with MODA Environmental Monitoring program updates and workflows to improve operation automation efficiency and validation documents associated with MODA implementation and lifecycle Review and TrendingReview microbiological and environmental monitoring trends for: Facilities Utilities Cleanrooms Water systems and Manufacturing data for scientific plausibility and compliance recurring issues and emerging trends that may impact product quality or patient with developing recommendations based on trend analysis and risk LeadershipProvide support for complex investigations involving:EM excursionsWater system excursionsOOS OOT OOEDeviationsContamination eventsData integrity concernsLaboratory investigationsAssist with root cause analysis using scientific and risk-based additional testing monitoring or investigative actions when investigations are timely scientifically justified and compliant with regulatory with QA and functional departments to drive closure of quality and Effectiveness ProgramAssist with Corrective and Preventative Actions (CAPAs).Monitor recurrence trends and identify opportunities for systemic Readiness and Regulatory SupportServe and an SME as needed during customer audits and regulatory inspections as FDA EMA MHRA and other health authority inspections as associated responses to regulatory observations and Skills and QualificationsBachelors Degree in Microbiology Biology Biotechnology Pharmaceutical Sciences Biochemistry or related scientific discipline preferred.3-5 years of pharmaceutical biotechnology or CDMO experience in Quality Control Microbiology Environmental Monitoring Quality Systems or related functions.1-3 years of leadership experience within EM Microbiology or pharmaceutical manufacturing in complex investigations and CAPAs or Change supporting inspections audits and associated supporting sterile parenteral with computerized environmental monitoring systems and validation KnowledgeEnvironmental monitoring programs and processesAseptic ManufacturingUtility and water system monitoringQuality SystemscGMP regulationsData integrityALCOAGood Documentation Practices (GDP)OOS/OOT/OOE InvestigationsDeviationsCAPA SystemsChange ControlRisk ManagementInspection readiness programsDigital SystemsMODA Environmental Monitoring Systems (or similar)LIMSElectronic Quality SystemsAudit Trail ReviewCompetencyExceptional scientific and technical attention to to recognize scientifically implausible results and data technical troubleshooting including common environmental monitoring to assess risk and make sound and root cause analysis written and verbal communication ability to collaborate effectively across functions and organization analytical critical thinking and decision-making We OfferCompetitive base salary performance bonusComprehensive benefits package (health dental vision 401k etc.)Structured mentorship and professional development programsExposure to cutting-edge pharmaceutical manufacturing technologiesClear career progression path toward Senior Manufacturing Engineer rolesCollaborative and supportive work culture#LI-Onsite