Summary

Supports either a key site department (i.e., Production, Packaging, QA, Tech Transfer and/or Engineering) to independently conduct a thorough and efficient investigation of process deviations and customer complaints as well as determine 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.

Job description

Job Summary

Supports either a key site department (i.e., Production, Packaging, QA, Tech Transfer and/or Engineering) to independently conduct a thorough and efficient investigation of process deviations and customer complaints as well as determine 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.

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 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 or managers 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
All employees are responsible for ensuring the compliance to company documents, programs and activities related to the Health, Safety, Environment, Energy, and Quality Management Systems, as per your roles and responsibilities

Requirements

BA/BS Degree in science field, e.g., Biology, Microbiology, Chemistry, Pharmacy, etc. or equivalent combination of education and experience
Minimum of 3 years of pharmaceutical or related work experience with emphasis on current Good Manufacturing Practices.
Good deductive and inductive critical thinking skills required.
Advanced writing 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.

Benefits

401(k) plan
Paid vacation
Holiday days
Personal days
Employee assistance program
Medical coverage
Prescription drug coverage
Dental coverage
Vision coverage
Life insurance
Disability insurance
Wellness program

Company overview

Fresenius Kabi USA is a leading global healthcare company and a subsidiary of Fresenius Kabi AG, specializing in pharmaceutical manufacturing and medical technologies. Headquartered in Lake Zurich, Illinois, the company operates as a comprehensive provider of essential medicines and technologies for critically and chronically ill patients. With over 43,000 employees globally and a presence in more than 100 countries, Fresenius Kabi USA focuses on four complementary business areas: Biopharma (biosimilars for autoimmune diseases and oncology), Pharma (IV drugs and infusion therapy), Medical Nutrition, and MedTech. The company's extensive portfolio includes injectable drugs, delivery systems, advanced transfusion medicine, cell therapy technologies, clinical nutrition products, and infusion devices. Serving hospitals, long-term care facilities, alternate care sites, and clinics, Fresenius Kabi USA is committed to providing high-quality, lifesaving medicines and technologies while driving healthcare transformation through innovation and patient-centric solutions.