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

• 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 electronic quality systems.
• 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/Material Review Board.
• Provides support in completing SOP changes as directed by the Investigation conclusions.
• Participates in and leads Deviation and Material Review Board (DMRB) and Quality Improvement Team (QIT) meetings to identify corrective actions to prevent repeat deviation recurrences.
• Utilizes Word, Visio, Excel, Documentum and other electronic systems to complete tasks.
• Maintains compliance with company policies, training requirements, cGMPs and safety standards.
• Perform any other tasks/duties as assigned by Management.

• REQUIREMENTS

• Bachelor of Science degree required.
• At least three years’ experience in a GMP manufacturing environment, writing standard operating procedures and protocols and/or reports is also required. Must be familiar with regulatory (FDA) requirements.
• Requires advanced critical thinking and technical writing skills.
• 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 match, 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.

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