Fresenius Kabi USA, LLC
Area of Interest
Fresenius Kabi is a global health care company that specializes in lifesaving medicines and medical technologies for infusion, transfusion and clinical nutrition. Our expansive portfolio of products and global network of science and manufacturing centers provide essential support for the care of critical and chronically ill patients. We are part of Fresenius SE, a health care group with more than 100 years of experience in pharmaceuticals, medical devices and life sciences. Our employees – more than 30,000 worldwide – develop and deliver injectable pharmaceuticals and infusion systems; blood collection, transfusion and cell technologies; and essential nutrients for parenteral nutrition.
Whether you work for us, buy from us, partner with us, or invest in us, you will come to know that caring is at the core of everything we do. Our purpose is to put lifesaving medicines and technologies in the hands of people who care for patients, and to find answers to the challenges they face every day.
The Technical Writer is responsible for independently investigating and reporting on deviations to the manufacturing process, customer complaints on finished product, and other manufacturing problems as assigned.
PRINCIPAL ACTIVITIES PERFORMED BY THE INCUMBENT
Responsible for describing problems, identifying possible causes, collecting and organizing existing data, comparing causes to facts, identifying probable root causes, and determining the best solutions in order to control the manufacturing process.
Responsible for managing multiple deviation investigations simultaneously.
Provides follow up and scheduling to ensure batch release process is not impacted by outstanding deviations.
Ensures investigations will withstand regulatory scrutiny and are compliant with cGMP regulations.
Works with process experts and production personnel to fully understand and solve problems,
Provides technical expertise and recommends improvements.
Writes Impact Assessments and Investigation Reports, works within TrackWise.
Assigns corrective/preventive actions (CAPAs) as necessary in order to resolve problems.
Performs continuous review and follow-up on investigations to minimize overall product impact and ensure the timely disposition of product that is directly affected.
Informs Management on the progress of on-going investigations, provides information to and takes direction from the Deviation Review Board.
Utilizes Word, Excel, Documentum and other electronic systems to complete tasks.
Maintains compliance with company policies, training requirements, cGMPs and safety standards.
Must have at least three years of experience in a GMP manufacturing environment, writing standard operating procedures and protocols and/or reports
Requires advanced critical thinking skills
Must be familiar with regulatory (FDA) requirements
Good organizational, communication, and interpersonal skills are necessary
We offer an excellent salary and benefits package including medical, dental and vision coverage, as well as life insurance, disability, and 401K with company match.
Fresenius Kabi is an Equal Opportunity/Affirmative Action employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disabilities, or protected veteran status.
Fresenius Kabi USA, LLC
Website : http://www.fresenius-kabi.com
Fresenius Kabi is a global healthcare company that specializes in lifesaving medicines and technologies for infusion, transfusion and clinical nutrition. Our products and services are used to help care for critically and chronically ill patients.