Compliance Officer

Fresenius Kabi USA•Melrose Park, IL

7d•$80,000 - $100,000

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, maintain a high level of compliance and regulatory audit readiness, and provide expertise in deviation and complaint investigations, annual product reviews, and CAPA system compliance. The Compliance Officer also reviews and approves documentation for regulatory correspondence. As needed, the Compliance Officer independently conducts thorough investigations of process deviations and customer complaints, determines root causes, and initiates corrective and preventive actions to address identified quality deficiencies. The role supports regulatory requests and audits, reviews manufacturing and laboratory documentation, and maintains quality management systems and related procedures. The position requires a bachelor's degree in a scientific or engineering field and at least three years of pharmaceutical-industry experience in compliance, technical writing, and/or regulatory affairs. The successful candidate must be able to speak, read, write, and understand English to perform the essential functions in a heavily regulated work environment.

Requirements

Bachelor's degree in a scientific or engineering field.
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 to perform the position's essential functions, including independently understanding English-language policies, procedures, training materials, and workplace communications.

Responsibilities

Complete and review deviation investigations and help define corrective actions to ensure non-conformances are evaluated completely, thoroughly, accurately, and promptly, and recurrence is prevented.
Complete and review investigations, gather information about products and risks to future operations, and maintain complaint information in FK gCMW KabiTrack systems.
Meet commitments agreed upon with department management to comply with 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 compliance to commitments made 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/or risk assessments of areas including manufacturing operations, laboratories, and maintenance and engineering to evaluate compliance with regulatory requirements such as cGMPs, FDA guidelines, and USP.
Update and maintain related quality management systems in compliance with governing procedures and policies for investigations, and perform trend analysis.
Ensure compliance with company documents, programs, and activities related to health, safety, environment, energy, and quality management systems, in accordance with assigned roles and responsibilities.