What are the responsibilities and job description for the Fresenius Kabi USA, LLC is hiring: TECHNICAL WRITER in Wilson position at Fresenius Kabi USA, LLC?
Job Summary
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.
Responsibilities
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.
REQUIREMENTS
Check appropriate highest level of Education required for position
Additional Information
We offer an excellent salary and benefits package including medical, dental and vision coverage, as well as life insurance, disability,401K with company contribution, andwellness program.
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, citizenship, immigration status, disabilities, or protected veteran status.
