Agilent inspires and supports discoveries that advance the quality of life. We provide life science, diagnostic and applied market laboratories worldwide with instruments, services, consumables, applications, and expertise. Agilent enables customers to gain the answers and insights they seek -- so they can do what they do best: improve the world around us. Information about Agilent is available at www.agilent.com.
The Genomics Quality Analyst will provide guidance and appropriate oversight for qualification of new equipment, instruments, including major capital projects and computer systems in manufacturing.
•Maintains and enhances validation programs for existing equipment, and manufacturing qualification, and computer systems.
•Reviews and approves protocols and reports related to equipment, facility, method, computer, and process validation. This includes deviation reporting during execution.
•Acts as Quality contact and primary Subject Matter Expert (SME) for Validation and Quality Risk Management
•Reviews and approves changes to critical processes, facilities, equipment and systems through the change control program to assess the impacts on validated systems.
•Quality representative for new product development projects.
•Identifies and assists with implementation of improvement opportunities for established Quality Systems, processes, procedures, and training to support CAPA, Change Control, Deviation, and Risk Management.
•Collaborates significantly with cross-functional groups, including Quality, Manufacturing, Process Development, Facilities, and Regulatory Affairs for New Product Introduction projects.
•Good Understanding of Risk Management for ISO 13485:2016 and QSR.
• BS or equivalent in Biological/Life Sciences, or related field required with 1-4 years of experience.
• Experience in FDA regulated environment, in vitro diagnostics/medical device preferred.
• Working knowledge of applicable standards and regulations, including CFR820, Part 11, ISO 13485, and ISO 14971.
• Experience with Medical Device preferred.
• Experience in a Quality Assurance role.
• Experience with verification and validation.
• Experience with the application of risk management tools.
• Working knowledge of spreadsheets and word processor applications.
• Working knowledge of analytical method, equipment, process, and software validations.
• Excellent attention to detail, strong organization skills, ability to work independently, and in teams.
• Excellent interpersonal, verbal and written communication skills.
• Ability to operate flexibly in a fast-paced environment.
• Experience with statistics, sampling plans, and statistical analysis preferred.
Agilent Technologies, Inc. is an Equal Employment Opportunity and Affirmative Action employer. We value diversity at all levels. All individuals, regardless of personal characteristics, are encouraged to apply. All qualified applicants will receive consideration for employment without regard to sex, pregnancy, race, religion or religious creed, color, gender, gender identity, gender expression, national origin, ancestry, physical or mental disability, medical condition, genetic information, marital status, registered domestic partner status, age, sexual orientation, military or veteran status, protected veteran status, or any other basis protected by federal, state, local law, ordinance, or regulation and will not be discriminated against on these bases.