MQA Specialist II

RXinsider LTD.; Melrose Park (IL); On-site; USD 60,000 - 90,000; Full time

Benefits offered by this job

Medical, dental, and vision coverage

Life insurance

Disability insurance

401K with company contribution

Wellness program

Job summary

Fresenius Kabi in Melrose Park, IL seeks a Quality Specialist to ensure quality requirements for manufactured items are met and to audit processes. You will maintain systems for timely delivery of quality products and report deviations impacting finished goods.

The role emphasizes adherence to internal and regulatory standards, with a focus on continuous improvement and risk mitigation. At-will employment and comprehensive benefits are included.

Qualifications

• Experience defining activities and processes to meet quality requirements.
• Auditing manufacturing processes against internal and regulatory standards.
• Reporting and troubleshooting deviations and defects.

Responsibilities

• Define and specify activities, processes, and standards to fulfill quality requirements for manufactured materials, components, or products.
• Build and maintain infrastructure and systems to ensure timely delivery of quality products.
• Audit, monitor, and determine quality of manufacturing processes and outputs against standards.
• Report and troubleshoot manufacturing process deviations and defects in finished goods.

Skills

Quality assurance

Process auditing

Regulatory compliance

Tools

GxP systems

Job description

Job Summary

Applies defined activities, processes, and standards to ensure quality requirements for manufactured items, maintains infrastructure for quality product delivery, audits manufacturing processes, and reports on process deviations and defects.

Responsibilities

The Specialist performs some or all of the following accountabilities as assigned:

• Defining and specifying activities, processes, and standards to fulfill the quality requirements for a manufactured material, component, or product
• Building and maintaining the infrastructure and systems necessary to consistently ensure the timely delivery of quality products
• Auditing, monitoring, and determining the quality of manufacturing processes and/or outputs against defined internal and regulatory standards
• Reporting and troubleshooting manufacturing process deviations and defects in finished goods

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, andwellness 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.