Colorado Veterans Jobs

Colorado Veterans Jobs

Job Information

Agilent Technologies Manufacturing Operations Investigator in Boulder, Colorado

Agilent 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 www.agilent.com.The world's most revolutionary biopharma companies are partnering withAgilent Technologies to advance the next frontier of medicine. Agilentcontinues to invest in capacity and expansion of its Colorado operations. Joinour team of professionals dedicated to the development and commercializationof nucleic acid therapeutics for life changing, lifesaving medicines.Agilent Technologies Life Sciences Chemical Analysis business is looking toadd an Operations Investigator / Technical Writer to their high-performancemanufacturing operations team working at the new state-of-the-art, contractAPI manufacturing facility that specializes in Nucleic Acid Chemistrieslocated in Frederick, Colorado.Manufacturing Operations Investigator / Technical Writer provides technicalwriting and compliance expertise within the Manufacturing Operationsdepartment. The role is responsible for the following activities:* Lead investigation activities by gathering information from internal andexternal sources to determine root cause, evaluate product and equipmentimpact, evaluate risk to previous or future batches and develop effectiveCAPAs* Author comprehensive investigation reports* Author and revise technical documentation including facility and equipmentSOPs.* Author and manage change controls and CAPAs.* Participate in customer and regulatory meetings and audits/inspectionsEssential Duties .and. Responsibilities:Deviation Investigation and CAPA:Thoroughly investigate deviation events utilizing root cause analysistechniques. Utilizes technical writing strategies to ensure content isclear, concise, and complete. Lead team to evaluate pertinent aspectsinvolved in determining deviation scope, root cause and impact. Identifynecessary CAPAs to address root cause and contributing causes discoveredduring investigation.Change 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 theOperations department in the following ways:* Complete deviations, CAPAs, change controls, document revisions andtraining activities to meet quality system requirements and timelines.* Represent deviations, CAPA, and change controls during customer meetingsand customer/regulatory inspections.To perform this job successfully, an individual must be able to perform eachessential duty satisfactorily. The requirements listed below arerepresentative of the knowledge, skill, and/or ability required.* Bachelor's degree or equivalent in a science-related field and/ orequivalent combination of education and experience.* 4+ years of related professional experience preferred.* Prior experience and/or training working in a GMP manufacturingenvironment is highly desired.* Knowledge of GMP guidelines as well as international regulations pertainingto the production of APIs and drug products.* Knowledge and understanding of the oligonucleotide manufacturing or relatedpharmaceutical manufacturing processes preferred.* Knowledge and experience authoring new facility and equipment SOPs usingdesign documents and equipment manuals.* Knowledge and experience with various root cause analysis methodologyrequired.*Skill in communication, written and verbal. Ability to leadcross-functional teams. Ability to interface with clients and regulatoryagencies as required.* Knowledge of and skill in using computer software and hardwareapplications, in

DirectEmployers