Compliance Officer

Fresenius Kabi USA; Melrose Park (IL); On-site; USD 80,000 - 100,000; Full time

Benefits offered by this job

401(k) plan

Paid vacation

Holiday and personal days

Employee assistance program

Medical coverage

Prescription drug coverage

Dental coverage

Vision coverage

Life insurance

Disability

Wellness program

Job summary

Fresenius Kabi USA seeks a Compliance Officer to manage Quality Systems from an FDA and global perspective, leading deviations investigations and CAPA actions. The role includes coordinating regulatory information, supporting audits, and maintaining regulatory readiness across the plant.

The candidate will review data for accuracy, participate in product quality reviews, and ensure adherence to cGMPs, FDA guidelines, and internal SOPs. Competitive benefits accompany the role.

Qualifications

• Bachelor's degree in a scientific or engineering field.
• 3+ years in pharmaceutical compliance, technical writing, and/or regulatory affairs.

Responsibilities

• Completes and reviews deviation investigations and defines corrective actions.
• Gathers information from product and evaluates risk to future operations; maintains complaint data in FK gCMW KabiTrack.
• Reviews manufacturing and laboratory documentation for accuracy and compliance with procedures.
• Acts as compliance SME for internal audits and supports external/regulatory audits.
• Coordinates information for regulatory requests and ensures compliance with commitments to authorities.
• Leads internal audits to identify and remediate noncompliance; supports annual product quality reviews.
• Performs GAP analyses and risk assessments to ensure regulatory compliance across operations.

Skills

Quality systems

Regulatory affairs

Technical writing

FDA compliance

Education

Bachelor's degree in Scientific or Engineering field

Tools

KabiTrack

Job description

Job SummarySalary Range: $80,000 to $100,000Final pay determinations will depend on various factors, including, but not limited to experience level, education, knowledge, skills, and abilities.Our benefits and programs are comprehensive and thoughtfully crafted to ensure our colleagues live healthy lives and have support when it matters most. Benefits offered include a 401(k) plan with company contributions, paid vacation, holiday and personal days, employee assistance program, and health benefits to include medical, prescription drug, dental and vision coverage. Read more about our benefits here.ResponsibilitiesThe Compliance Offer works with the Compliance Management Team to administer and maintain the Quality Systems in place at the production unit from an FDA and global perspective. This function leads teams and projects identity and correct cGMP inadequacies and ensures a high-level of compliance and regulatory audit readiness. The incumbent provides expertise in deviation and compliant investigations, annual product reviews, and helps maintain the compliance of the CAPA systems, as well as, reviewing and approving necessary documentation for regulatory correspondence.As needed, the Compliance Officer is independently responsible for the efficient and thorough investigation of process 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 during the investigation process.Job Responsibilities:Completes / reviews deviation investigations and helps define necessary corrective actions to ensure complete, thorough, accurate, and timely evaluation of non-conformances and prevention of recurrence.Completes / reviews investigations. As part of each investigation, gathers information from all product, as well as the risk to future operations. Maintains complaint information in FK gCMW KabiTrack systems.Accountable for commitments agreed upon with department management to comply with closure targetsReviews and analyzes manufacturing and laboratory analytical documentation for accuracy and compliance to establish proceduresServes as the compliance SME for all internal audits and supports external and regulatory authority auditsCoordinates the collection of information for all regulatory requests and assists in the compliance to commitments made to all regulatory authoritiesLeads internal audit teams to inspect and remediate system and process noncompliance in the plantSupports compilation of annual product quality reviewResponsible for ensuring compliance with relevant operating proceduresAssists in the execution of GAP analysis and/or risk assessments to ensure evaluation of key areas, such as manufacturing operations, laboratory, and maintenance and engineering, are in compliance with all regulatory requirements (e.g. cGMPS, FDA Guidelines, USP, etc.)Updates and maintains all related quality management systems in compliance with various governing procedures and policies as they relate to investigations and performs trend analysisAll employees are responsible for ensuring the compliance to company documents, programs and activities related to health, safety, environment, energy, and quality management systems, as per their roles and responsibilities.Job Requirements:Bachelor's degree in Scientific or Engineering degreeMinimum 3 (three) years of experience in the pharmaceutical industry in compliance, technical writing, and/or regulatory affairsThe 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 InformationWe 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.