Colorado Engineering Jobs

Colorado Jobs

Job Information

Agilent Technologies Supplier Quality Management Specialist, Quality Assurance in Boulder, Colorado

Job FunctionQuality/RegulatoryTravel RequiredYes, 25% of the TimeJob 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 position provides Quality Assurance (QA) oversight to Suppliers,Service Providers and Contract Labs to ensure compliance with applicableregulatory requirements and Standard Operating Procedures (SOPs). Servesas the quality liaison to suppliers and executes and manages on-goingqualification for Suppliers, Service Providers, and Contract Labs.Primary Duties and Responsibilities for the Supplier Quality ManagementSpecialist include the following:Manages or supports the supplier management program. Suggests, developsand/or implements improvements to the program to ensure it maintainscompliance with current regulatory and industry expectations.Performs on-site audits to ensure compliance to regulatory standards andinternal procedures. Completes audit reports and ensures appropriate CAPAsare identified by the supplier when necessary. Site audits require up to25% travel, both domestic and international.Performs desktop audits to ensure compliance to regulatory standards.Owns the Material Review Board process. Schedules and facilitates meetingsensuring cross-functional input and decision making on supplier-relatedtopics, including real-time monitoring of supplier performance anddocumentation of supplier scorecards.Manages Supplier Complaints to ensure the investigation into issues arecompleted and appropriate CAPAs are identified and implemented by thesupplier.Manages the Raw Material Change Evaluation process.Manages and maintains Quality Agreements with suppliers.Provides input into investigations involving Supplier/ServiceProvider/Contract Lab deviations.Responsible for writing, reviewing and/or approving documentation andprocedures related to the supplier management program.Provides support on various other quality assurance issues as necessary.May disposition raw materials, including rejection of materials incollaboration with the Manufacturing QA team.Assists with client and regulatory audits as requested by management.Assists in conducting internal audits as requested by management.Option to Work RemoteNoScheduleFull-timeSecondary LocationsJob TypeExperiencedShiftDay ShiftQualificationsBachelors or Master Degree or University Degree or equivalent6+ years of relevant QA experience, with 2+ years of auditing experienceKnowledge of GMP guidelines as well as international regulations pertaining tothe production of APIs and drug products.Knowledge and understanding of oligonucleotide manufacturing or relatedpharmaceutical... For full info follow application link.Agilent Technologies, Inc. is an Equal Employment Opportunity andAffirmative Action employer. We value diversity at all levels. Allindividuals, regardless of personal characteristics, are encouraged toapply. All qualified applicants will receive consideration for employmentwithout regard to sex, pregnancy, race, religion or religious creed,