Compliance Officer

Fresenius Kabi•Melrose Park, IL

11d

About The Position

The Compliance Officer works with the Compliance Management Team to administer and maintain production-unit quality systems from FDA and global perspectives. The role leads teams and projects to identify and correct cGMP inadequacies and support a high level of compliance and regulatory audit readiness. The officer provides expertise in deviation and complaint investigations, annual product reviews, and CAPA system compliance, and reviews and approves documentation for regulatory correspondence. As needed, the officer independently investigates process deviations and customer complaints, determines root causes, and initiates corrective and preventive actions to address identified quality deficiencies.

Requirements

Bachelor's degree in a scientific or engineering discipline.
At least 3 years of experience in the pharmaceutical industry in compliance, technical writing, and/or regulatory affairs.
Ability to effectively speak, read, write, and understand English, including independently understanding policies, procedures, training materials, and workplace communications.

Responsibilities

Complete and review deviation investigations and define corrective actions to ensure thorough, accurate, and timely evaluation of non-conformances and prevent recurrence.
Gather information for investigations across products and assess risks to future operations.
Maintain complaint information in FK gCMW KabiTrack systems.
Meet commitments agreed upon with department management for closure targets.
Review and analyze manufacturing and laboratory analytical documentation for accuracy and compliance with established procedures.
Serve as the compliance subject matter expert for internal audits and support external and regulatory authority audits.
Coordinate collection of information for regulatory requests and assist with meeting commitments to regulatory authorities.
Lead internal audit teams to inspect and remediate system and process noncompliance in the plant.
Support compilation of annual product quality reviews.
Ensure compliance with relevant operating procedures.
Assist in executing gap analyses and risk assessments to evaluate manufacturing operations, laboratories, maintenance, and engineering against regulatory requirements, including cGMPs, FDA guidelines, and USP requirements.
Update and maintain quality management systems in accordance with governing procedures and policies related to investigations, and perform trend analysis.
Ensure compliance with company documents and programs related to health, safety, environment, energy, and quality management systems, as applicable to the role.