Sr. Technical Writer

301044 Fresenius Kabi USA, LLC; North Carolina; On-site; USD 74,000 - 104,000; Full time

Benefits offered by this job

401(k) plan with company contributions

paid vacation

holiday and personal days

employee assistance program

health benefits to include medical, Rx

dental and vision coverage

life insurance

disability

wellness program

Job summary

Fresenius Kabi USA is seeking a quality investigator to independently oversee the thorough examination of process deviations and customer complaints. You will determine root causes and initiate CAPA actions to address quality deficiencies, aiming to minimize recurrence and potential product actions.

The role requires handling investigations end-to-end with minimal supervision. The position includes accountability for timely investigations, trend-based corrections, and coordination with senior

Responsibilities

• Investigate process deviations and customer complaints, determine root causes and initiate corrective/preventive actions.
• Provide proactive corrections based on trend analysis to reduce recurrence and potential product recalls or field actions.
• Manage investigations from initiation to completion with minimal supervision.
• Assess manufacturing or analytical environments and advise senior management on appropriate actions.

Job description

Job Summary

Independently responsible for the efficient and thorough investigation of process deviations and customer complaints, determination of root cause, and initiation of corrective/preventative actions designed to adequately address and correct the Quality related deficiencies identified during the investigation process. Responsible to provide proactive corrections based on noted trends to minimize the potential for repeat incidents that may lead to, or result in, the issuance of Product Discards, Field Actions, or Recalls. The position requires working with minimal supervision to manage assigned investigations from initiation to completion.

Salary Range: $73,614- $103,528 Position is eligible to participate in a bonus plan with a target of 6% of the base salary Final pay determinations will depend on various factors, including, but not limited to experience level, education, knowledge, skills, and abilities.

Benefits & Compensation

Our benefits and programs are comprehensive and thoughtfully crafted to ensure our colleagues live healthy lives and have support when it matters most.

• 401(k) plan with company contributions
• paid vacation
• holiday and personal days
• employee assistance program
• health benefits to include medical, prescription drug, dental and vision coverage
• medical, dental and vision coverage
• life insurance
• disability
• 401(k) with company contribution
• wellness program

Responsibilities

• Responsible for ensuring compliance with relevant Standard Operating Procedures, while gathering, analyzing and applying information from internal and external sources in order to perform a risk assessment of the impact each process deviation and complaint has on the product, process, and patient health and safety.
• As part of each investigation, gathers information from all necessary internal and external sources in order to evaluate the impact of the deviation on previously manufactured product, as well as the risk to future operations.
• Prepares and analyzes manufacturing and laboratory analytical historical data and uses methodical root-cause analysis tools to determine root causes and effectively communicates the root cause to senior management.
• The incumbent will need to properly assess the manufacturing or analytical environment, independently conceive, and advise senior management on appropriate corrective/preventative actions designed to mitigate Quality deficiencies identified in the investigative process using industry accepted analytical tools.
• The individual in the position provides technical expertise to the site to ensure that investigation corrective and preventative actions are complete, thorough, accurate, and timely.
• Updates and maintains all related enterprise quality management systems in compliance with various governing procedures and policies as they relate to investigations and performs trend analysis.
• Works independently to comply with procedure driven guidelines relating to Deviation and complaint investigations and makes decisions that directly affect patient health and safety.
• Demonstrates strong technical skills; provides technical assistance to area supervisors, managers, and technical writers to solve complex problems.
• Ensures that deadlines are maintained and closely monitors the need for extensions to be administered in relation to Subsequent Actions and Investigations in order to maintain compliance in this area.
• Accountable for commitments agreed upon with department management.
• Required to comply with closure targets and provide adequate justification if commitments are not met.
• All employees are responsible for ensuring the compliance to company documents, programs and activities related to Health, Safety, Environment, Energy and Quality Management System as per your roles and responsibilities.
• Any other task as directed or requested by management or site leadership.

Equal Opportunity

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.

Employment Terms

All employment is at-will, meaning both the employee and Fresenius Kabi have the right to end the employment relationship at any time, in accordance with applicable federal and state laws.

About Fresenius Kabi

Fresenius Kabi is a global health care company that specializes in injectable medicines, biosimilars, and 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. With more than 41,000 employees worldwide, our dedicated team is united by our shared purpose: to put lifesaving medicines and technologies in the hands of people who care for patients – and to find answers to the challenges they face. We call this purpose caring for life. Our U.S. headquarters is in Lake Zurich, Illinois and the company's global headquarters is in Bad Homburg, Germany.

Follow us on LinkedIn to learn more: http://bit.ly/3KdaGJr