Agilent Technologies Compliance Specialist MFG Operations in Boulder, Colorado

Description: Agilent inspires and supports discoveries that advance the quality of life.We provide life science, diagnostic and applied market laboratoriesworldwide with instruments, services, consumables, applications andexpertise. Agilent enables customers to gain the answers and insights theyseek -- so they can do what they do best: improve the world around us.Information about Agilent is available at www.agilent.com.The world s most revolutionary biopharma companies are partnering with AgilentTechnologies to advance the next frontier of medicine. Agilent continues toinvest in capacity and expansion of its Colorado operations. Join our team ofprofessionals dedicated to the development and commercialization of nucleicacid therapeutics for life changing, lifesaving medicines.The Operations Compliance Specialist provides technical writing and complianceexpertise within the Manufacturing Operations department.The role is responsible to lead the following compliance activities:* Lead deviation investigations* Identify necessary Corrective and Preventative Actions (CAPA)* Change control ownership* Standard Operating Procedure revisions* Participate in customer meetings and audits/inspectionsEssential Duties & 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 to SOPs andforms to facilitate improvements driven by the deviation, CAPA andcompliance 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.*Identify, propose and execute CAPAs and procedural changes to reducedeviations. Qualifications: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.* 2+ years of related professional experience.* Prior experience and/or training working in a GMP manufacturingenvironment is required.* 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.*Skill in communication, written and verbal; will be handling variousrelations issues and will be confronted with various interactions.* Knowledge of and skill in using computer software and hardwareapplications, including Microsoft products and the internet, are required.Advanced computer skills, especially with Microsoft Word, are preferred.* Skill in managing various projects; must be able to use individualdiscretion in completing work assignments; while assisting the group inestablishing priorities, setting standards and working collectively toaccomplish deadlines and objectives.* Ability to read, analyze, and interpret industry related periodicals,SOPs, and government regulations.* Ability to write reports, business correspondence, and procedures.* Ability to respond to common inquiries or complaints from customers,co-workers, subordinates, and supervisors regarding the products andprocesses.Agilen