SR. TECHNICAL WRITER

Fresenius Kabi USA, LLC; Wilson (NC); Vor Ort; USD 74.000 - 104.000; Vollzeit

Benefits dieser Stelle

401(k) plan with company contributions

Paid vacation, holidays and personal/休

Health benefits: medical, prescription

Dental and vision coverage

Life insurance

Disability

Wellness program

Zusammenfassung

Fresenius Kabi USA, LLC is seeking an investigator to independently manage process deviation and customer complaint investigations from initiation to completion, ensuring thorough root-cause analysis and timely corrective actions.

The role involves risk assessment, data review from multiple sources, and collaboration with senior management to prevent reoccurrence, while adhering to SOPs and health and safety standards. Competitive salary and comprehensive benefits are offered.

Qualifikationen

• Independent investigator for deviations and customer complaints
• Root-cause analysis using standard tools
• Timely corrective/preventative actions to prevent recurrence

Aufgaben

• Ensure SOP compliance and gather/analyze information to assess impact on product and patient safety
• Evaluate deviation impact on previously manufactured products and future operations risk
• Use root-cause analysis tools to identify causes and communicate findings to senior management
• Advise on corrective/preventative actions to mitigate quality deficiencies
• Provide technical expertise to ensure investigations are complete, accurate and timely
• Update and maintain quality management systems and perform trend analysis
• Work independently under procedure-driven guidelines for investigations
• Monitor deadlines and extensions for subsequent actions and investigations
• Support commitments with management and justify if not met
• Adhere to Health, Safety, Environment, Energy and Quality policies
• Perform any other tasks as directed by management

Kenntnisse

Root cause analysis

Risk assessment

Investigation management

Jobbeschreibung

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.

Our benefits and programs are comprehensive and thoughtfully crafted to ensure our colleagues live healthy lives and have support when it matters most. Benefits offered include a 401(k) plan with company contributions, paid vacation, holiday and personal days, employee assistance program, and health benefits to include medical, prescription drug, dental and vision coverage.

Responsibilities

PRINCIPAL ACTIVITES PERFORMED BY THE INCUMBENT

• 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.

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.

Please note that joining our team does not create a guaranteed or permanent employment arrangement. All employment is atwill, 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.

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.