Quality Systems Specialist

CSL Behring • Kankakee, IL

23h

About The Position

Provides oversight for the development and maintenance of quality programs, systems, processes, and procedures to ensure compliance with company standards and regulatory guidelines. Supports the Quality Compliance organization across Quality Systems, Inspections, and Performance. Leads or facilitates deviation investigations, complaints, and issue resolution within QA Compliance and CSL Contracted Manufacturing Operations (CMO).

The role coordinates Annual Product Quality Review (APQR) initiatives, including contributing report timelines, executive summary creation, and issue escalation, while meeting required deadlines. Under general supervision, the specialist maintains the Quality Assurance System in compliance with company and cGMP standards. The specialist serves as the site APQR coordinator, works with subject matter experts to author APQR contributing reports for each product produced at Kankakee, and authors the associated executive summary. The role also maintains local APQR and deviation processes, updating SOPs or other official documents as needed.

The specialist leads investigations of deviations identified by Compliance or entered by the site CMO, managing them to meet timing commitments and produce thorough, well-documented reports. The specialist provides direction to support timely and consistent completion of investigations, with reports that can stand alone during regulatory inspections, collaborating closely with relevant teams. The role assists the QA Systems Lead in identifying potential process or system deviation and incident issues and communicating them to Compliance.

The position promotes continuous improvement through employee selection, training, and mentoring, with an emphasis on operational efficiency and eliminating non-value-added activities. It participates in or leads self-inspections, internal audits, and regulatory inspections, identifying facility improvements through these processes. The specialist must comply with CSL Behring's Safety Program, including health and safety mandates and OSHA requirements, and complete other duties assigned by Senior Management.

CSL Behring describes itself as a global biotherapeutics leader focused on developing and delivering therapies across several therapeutic areas. The company states that inclusion and belonging are central to its mission and that it is an Equal Opportunity Employer.

Requirements

• Bachelor of Arts or Bachelor of Science degree, preferably in a scientific or technical field such as chemistry, biology, physics, engineering, computer science, or technical writing; equivalent work experience and/or knowledge may be considered in lieu of the degree.
• At least 3 years of experience working in a cGMP-regulated environment, such as quality, manufacturing, or engineering, applying cGMP rules in everyday activities.
• Technical writing experience.
• A proven ability to perform in the role may be considered in lieu of the stated education or experience qualifications.
• Must comply with CSL Behring safety requirements, including health and safety mandates and OSHA requirements.

Responsibilities

• Maintain the Quality Assurance System to ensure compliance with company and cGMP standards.
• Coordinate site APQR activities, collaborating with subject matter experts to author contributing reports for each product produced at Kankakee and authoring the associated executive summary.
• Maintain local APQR and deviation processes and update SOPs or other official documents as required.
• Lead investigations of deviations identified by Compliance and deviations entered by the site CMO; manage investigations to meet timing commitments and produce well-investigated, well-documented reports.
• Provide direction and support timely, consistent completion of deviation investigations, collaborating with necessary teams so reports can stand alone during regulatory inspection.
• Assist the QA Systems Lead in identifying potential deviation or incident issues with processes or systems and communicate them to Compliance.
• Drive APQR initiatives, including contributing report timelines, executive summary creation, issue escalation, and meeting required deadlines.
• Foster continuous improvement through employee selection, training, and mentoring, focusing on operational efficiency and eliminating non-value-added activities.
• Participate in or lead self-inspections, internal audits, and regulatory inspections, identifying facility improvements through the process.
• Comply with CSL Behring's Safety Program, including health and safety mandates and OSHA requirements.
• Complete other duties and responsibilities assigned by Senior Management.
• Support Quality Compliance across Quality Systems, Inspections, and Performance, including deviation, complaint, and issue resolution within QA Compliance and CSL CMO.

Benefits

• The posting mentions that total compensation may include incentive compensation and equity, in addition to base salary.
• The posting directs candidates to CSL's benefits information but does not specify individual benefits.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level