Agilent Technologies QC Investigator in Boulder, Colorado
Job FunctionQuality/RegulatoryTravel RequiredOccasionalJob DescriptionAgilent inspires and supports discoveries that advance the quality of life. Weprovide life science, diagnostic and applied market laboratories worldwidewith instruments, services, consumables, applications and expertise.Agilent enables customers to gain the answers and insights they seek -- sothey can do what they do best: improve the world around us. Informationabout Agilent is available at .The world's most revolutionary biopharma companies are partnering withAgilent Technologies to advance the next frontier of medicine. Agilentcontinues to invest in the capacity and expansion of its Colorado operations.Join our team of professionals dedicated to the development andcommercialization of nucleic acid therapeutics for life-changing,life-saving medicines.Agilent Technologies, Inc. is looking to add a Quality Control Investigatorto its high-performance quality team working at the state-of-the-art,contract API manufacturing facility that specializes in Nucleic AcidChemistries located in Boulder and/or Frederick, Colorado.QC Investigator:QC Laboratory Investigator/Technical Writer provides technical writing andcompliance expertise within the QC department. The role is responsible for thefollowing activities:Lead investigation activities by gathering information from internal andexternal sources to determine root cause, evaluate instrument and equipmentimpact, evaluate the risk to previous or future batches and developeffective CAPAs.Author comprehensive investigation reportsAuthor and revise technical documentation including facility and equipmentSOPs.Author and manage change controls and CAPAs.Participate in customer and regulatory meetings and audits/inspectionsInvestigation and CAPA:Thoroughly investigate laboratory, out-of-specification (OOS) andout-of-trend (OOT) events using root cause analysis techniques. Usestechnical writing strategies to ensure content is clear, concise, andcomplete. Lead team to evaluate pertinent aspects involved in determininginvestigation scope, root cause and impact. Identify necessary CAPAs toaddress the root cause and contributing causes discovered during aninvestigatiChange Control Management and Document Revisions:Write and manage change controls as necessary to implement changes todocumentation and SOPs to facilitate improvements driven by the deviation,CAPA and compliance inspection systems.Customer and Regulatory Support:Responsible for maintaining compliance and inspection readiness within the QCdepartment bycompleting investigations, CAPAs, change controls, document revisions,and training activities to meet quality system requirements and timelines,and representing deviations, CAPA, and change controls during customermeetings and customer/regulatory inspections.Job TypeExperiencedShiftDay ShiftQualificationsBachelor's degree or equivalent in a science-related field and/ orequivalent combination of education and experience.4+ years of related professional experience.Knowledge of GMP guidelines as well as international regulations pertaining tothe production of APIs and drug products.Knowledge and experience with various root cause analysis methodology.Agilent Technologies, Inc., is committed to diversity in the workplace andstrives to support candidates with disabilities. If you have a disability andneed assistance with any part of the application or... For full info followapplication link.