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

 

·        BS/BA degree (experience may be considered in lieu of degree).

·        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

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, and wellness 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.