Quality Control Analyst

4 days ago

Durham, United States Pacer Group Full time

Job DescriptionJob Title: Associate Specialist, QCDuration: 23 MonthsLocation: Durham, NC 27712Pay Rate: $31/hr on W2Shift: Monday – Friday 10:00 AM to 6:00 PM ESTEducation/Experience Requirements• Associate'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 fieldRequired Experience and Skills• Understanding and application of Good Laboratory Practices and cGMPs• Aseptic technique• Performance of environmental and water systems monitoring• Working in a team environmentPreferred Experience and Skills• Strong verbal and written communication skills• Experience with LIMS, SAP or other laboratory/production software systemsWorking Relationships• Reports to Quality Control manager• Interacts with employees within own department and other departmentsAdditional InformationOur Quality group ensures every single material inside our products is manufactured, processed, tested, packaged, stored and distributed aligned with our incredibly high standards of quality and meets all regulatory requirements. Partnering across our internal manufacturing facilities, external contract manufacturers and suppliers we create an interdependent global manufacturing network committed to deliver a compliant, reliable supply to customers and patients on time, every time, across the globe.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.ResponsibilitiesGeneral• Conducts release testing in support of finished product• 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• Maintains lab materials and reagentsBusiness & Functional Expertise• Completes assignments in alignment with department objectives• Conducting In-Process and Release testing• Conducting Environmental Monitoring of processes and on a routine basisProblem Solvingo Identifies and resolves technical and operational problems in collaboration with colleagues and under guidance from department headImpactInfluenceo Communicates information, asks questions and checks for understandingAccountabilityo Accountable for own performanceDecision Makingo Makes decisions – guided by policies and procedures – on the shop flooro 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

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