Responsible for ensuring compliance with relevant standard operating procedures, while gathering, analyzing and applying information from internal and external sources 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 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.
-Will work with Investigative Writers / Supervision for further development of root cause analysis and proposals for corrective actions.
- 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.
Complies with procedure driven guidelines relating to deviation and complaint investigations and makes recommendations to supervision and management regarding decisions that directly affect patient health and safety.
- Demonstrates technical skills
- Ensures that deadlines are maintained and closely monitors the need for extensions to be administered in relation to subsequent actions and investigations to maintain compliance in this area.
All employees are responsible for:
- Protecting the environment
- Preventing pollution
- Complying with applicable requirements as identified in the policy statements
- Promoting sustainable practices
- Working in accordance with the documented environmental procedures and policies, specific responsibilities defined
- Reporting problems or deviations associated with environmental issues and the EMS to the EMR.
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, disabilities, or protected veteran status.