QC Investigator-Technical Writer
Agilent frederickUpdate time: May 27,2020
Job Description
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 http://www.agilent.com.
Agilent Technologies, Inc. is looking to add an Quality Control (QC) Investigator/Technical Writer to their high-performance quality team working at the state-of-the-art, contract API manufacturing facility that specializes in Nucleic Acid Chemistries located in Frederick, Colorado.
The world's most revolutionary biopharma companies are partnering with Agilent Technologies to advance the next frontier of medicine. Agilent continues to invest in capacity and expansion of its Colorado operations. Join our team of professionals dedicated to the development and commercialization of nucleic acid therapeutics for life changing, lifesaving medicines.
This position will support the laboratory quality system by conducting investigations into laboratory nonconformances including Out of Specification (OOS), Out of Trend (OOT) and unexpected laboratory results Including by not limited to QC microbiology, raw materials, manufacturing in-process testing and final API release testing. In this position, you will work in conjunction with site Quality Assurance (QA), QC Analysts and management. Responsibilities include interviewing QC analysts/management, documenting nonconforming events and investigating the root cause of the issue using root cause analysis tools (6M, 5 why...) and contributing to appropriate corrective and preventive actions (CAPA) and ownership of effectiveness verification (EV).
You will provide technical writing and compliance expertise within the QC department. The role is responsible for the following activities:
* Lead investigation activities by gathering information from internal and external sources to determine root cause, evaluate product and equipment impact, evaluate the risk to previous or future batches and develop effective CAPAs
* Author comprehensive investigation reports
* Author and revise technical documentation including facility and equipment SOPs
* Author and manage change controls and CAPAs
* Participate in customer and regulatory meetings and audits/inspections
You will also work on complex problems and requires experience with Quality Control and/or Quality Assurance, Investigation of nonconforming events, root cause analysis tools and CAPA.
ESSENTIAL DUTIES AND RESPONSIBILITIES:
Exercises judgment within broadly defined practices and policies
Outstanding communication skills, both written and oral, and the ability to communicate directly with peers and area managers
Conducts investigations into Laboratory nonconforming events associated with clinical and commercial analytical results under current Good Manufacturing Practices (cGMP) regulations and guidance per Food and Drug Administration (FDA) and Organization for Economic Co-Operations and Development (OECD)
Investigates and resolves laboratory testing issues and drives solutions to improve laboratory programs through corrective and preventive actions
Partners with QA and QC staff to drive process improvements and appropriate CAPAs from NC trends
Ensures good documentation practices are followed
Works cross-functionally to complete investigations
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