Quality Control Microbiology Associate
Title: Quality Control Microbiology AssociateLocation: Durham, NC 27712100% OnsiteDuration: 12+ Months ContractWork Schedule:1st Shift Days - Weekends RequiredShift available: (Sunday – Thursday) and (Tuesday – Saturday)Hours: 8:30 AM – 5:00 PMFlexibility for earlier or later start times depending on Environmental Monitoring (EM) needs.Shift Duration: 8 hours with a 30-minute lunch break.Position SummaryQuality Control Lab Associate Specialist performing environmental monitoring and quality control assays.The main function of the Associate Specialist, Quality Control is to assist in the assurance of the quality of product through the performance of microbiological, chemical and analytical sampling and assays as well as interacting with Production, Quality Assurance, Validation and Facilities, and external resources, as necessary to support Manufacturing.Key ResponsibilitiesGeneral ResponsibilitiesConducts release testing in support of finished product, including sterility testing, detection of residual moisture, average cell dry weight testing.Conducts microbiological testing; evaluation of environmental microbiological samples.Conducts environmental monitoring sampling to include active air and surface sampling and water sampling.Evaluates data, conducts trouble shooting, process improvements, report writing, involvement in interdepartmental committees and projects.Business & Functional ExpertiseCompletes assignments in alignment with department objectives.Conducting In-Process and Release testing.Conducting Environmental Monitoring of processes and on a routine basis.Problem SolvingIdentifies and resolves technical and operational problems in collaboration with colleagues and under guidance from department head.Communication & CollaborationCommunicates information, asks questions and checks for understanding.AccountabilityAccountable for own performance.Decision MakingMakes decisions – guided by policies and procedures – on the shop floor.Consults on an as-needed basis with next-level manager on more complex decisions and/or issues that impact other units with inter-related processes.Education & Experience RequirementsAssociate's degree in Biology, Microbiology, Biochemistry, or related field plus 1-2 years of relevant laboratory/pharmaceutical experience.Bachelor's degree in Biology, Microbiology, Biochemistry, or related field.Required Experience & SkillsUnderstanding and application of Good Laboratory Practices and cGMPs.Aseptic technique.Performance of environmental and water systems monitoring.Working in a team environment.Preferred Experience & SkillsStrong verbal and written communication skills.Experience with LIMS, SAP or other laboratory/production software systems.Working Relationships & Reporting StructureReports to Quality Control manager.Interacts with employees within own department and other departments.