Final QC Technical Lab Lead

DescriptionPosition SummaryProvide direction to the Lab team including communicating lot status and priorities to the group and demonstrating good aseptic lab practices. Prioritize lab tasks to ensure the schedule is met. Assists and trains others as needed in performing and documenting testing. In addition, the position is responsible for ensuring proper documentation according to cGMP's and current procedures. Using good aseptic lab practices, it supports performance testing and physical inspections of finished good lots and internal use only lots through set up of VITEK2 cards, to completion.Primary DutiesPerformance testing per procedure and scheduleMaintain records for defect traceability and trendingProvide training, guidance, and assistance to other team members. Train lab team to waivers (as applicable)Organism subculturing and/or slurry preparationSchedule work tasks for department team members, ensuring deadlines are metOperate, train, and support troubleshooting of instrument and equipment issues, perform root cause analysis as appropriateOperating and troubleshooting of instrumentation used in performance testingLead efforts to ensure continuous product and process improvement in Final QC lab (5S, Gemba)Provide technical writing for procedural updates and review updates before submittal to document control.Support QC and special projects as requested by managementEnvironmental Monitoring of surface, air, water (as applicable)Collaboration with operations, technical teams, and validation teamsPerform other tasks as applicable per managementQualification and ExperienceThe role requires High School Diploma ,GED or equivalent and 5+ years cGMP laboratory and or medical laboratory experience.1 year progressively responsible lab experience including independent project management or equivalent experience is preferred.Knowledge Skills and AbilitiesConsistently upholds and reflects the core ethical principles and values that bioMérieux promotes.Written Communications - including the ability to communicate technical data in written formDemonstrates assertiveness and confidence in the face of a challengeOrganizing work and resources efficiently to ensure smooth operationsBuild and maintain positive, productive interactions with colleaguesDrive for Results: Drive for Results while successfully removing barriersIntermediate: applies skills independently in most situations; handles moderately complex tasks with occasional guidanceMust have a strong knowledge of antibiotic / microorganism interactions and GMP compliance (6 months)Must have a minimum of one year progressively responsible lab experience (including independent project management or equivalent experience)#biojobs