Job Summary

Works with Supervision and Senior Technical Writers to investigate 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 efficiently and thoroughly during the investigation process. Responsible to recommend proactive corrections, corrective actions and preventative actions 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 moderate supervision to manage assigned investigations from initiation to completion.

Salary Range: $60,966-$85,694 annually

Final pay determinations will depend on various factors, including, but not limited to experience level, education, knowledge, skills, and abilities.

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.
• Will work with Senior Technical 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.
• Works independently to comply with procedure driven guidelines relating to Deviation and complaint investigations and supports management decisions that directly affect patient health and safety.
• Demonstrates strong technical skills
• 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.

Requirements:

• Bachelor’s degree with 1-2 years of experience in pharmaceutical manufacturing or cGMP environment.
• Associates degree with 5 years of experience in pharmaceutical manufacturing or cGMP environment.
• Working knowledge of GMP, EU, and GLP, as well as FDA trends and guidelines.
• Excellent verbal and written communication skills required
• Good deductive and inductive critical thinking skills required.
• Candidate must possess strong interpersonal, written, and verbal communication skills. Incumbent must be able to interface positively with Regulatory Agencies, vendors, and company departments. Good knowledge of MS Office programs, including Word and Excel.
• The Company’s primary business language is English. The successful candidate must be able to effectively speak, read, write, and understand English to perform the essential functions of the position, including independently understanding policies, procedures, training materials, and workplace communications written in English due to our heavily regulated work environment.

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.

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

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.