Quality Systems Specialist

CSL • Kankakee, IL

2d • $76,000 - $95,000

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, including Quality Systems, Inspections, and Performance. Leads or facilitates deviation investigations, complaints, and issue resolution within QA Compliance and CSL Contracted Manufacturing Operations (CMO). Drives Annual Product Quality Review (APQR) initiatives, including report timelines, executive summary creation, and issue escalation to meet required deadlines.

The role maintains the Quality Assurance System under general supervision and coordinates site APQR activities. It collaborates with subject matter experts to prepare contributing reports for products produced at Kankakee and authors the related executive summary. The position 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 investigations to meet timing commitments and produce thorough, well-documented reports. The role provides direction to support consistent, timely investigations and works with relevant teams so reports can stand alone during regulatory inspections. It also supports identification and communication of potential process or system issues, promotes continuous improvement through employee selection, training, and mentoring, and participates in audits and inspections. The role must comply with CSL Behring’s Safety Program, including Health and Safety mandates and OSHA requirements, and perform other duties assigned by Senior Management.

Requirements

• B.A. or B.S. degree, preferably in a scientific or technical field; equivalent work experience and/or knowledge may be considered instead.
• 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 required.
• A proven ability to perform in the role may be considered in lieu of the stated education or experience qualifications.

Nice To Haves

• A degree in a scientific or technical field such as chemistry, biology, physics, engineering, computer science, or technical writing.

Responsibilities

• Maintain the Quality Assurance System under general supervision to ensure compliance with company and cGMP standards.
• Coordinate site APQR activities and collaborate with subject matter experts to author contributing reports for each product produced at Kankakee.
• Author the associated APQR executive summary report.
• Maintain local APQR and deviation processes, updating SOPs and associated official documents as required.
• Lead and manage investigations of deviations identified by Compliance or entered by the site CMO, meeting timing commitments and ensuring reports are well investigated and documented.
• Provide direction and collaborate with necessary teams to ensure timely, consistent deviation investigations and reports suitable for regulatory inspection.
• Assist the QA Systems Lead in identifying potential deviation or incident issues with processes or systems and communicate them to Compliance.
• Promote continuous improvement through employee selection, training, and mentoring, with attention to operational efficiency and eliminating non-value-added activities.
• Participate in or lead self-inspections, internal audits, and regulatory inspections, identifying facility improvements.
• Comply with CSL Behring’s Safety Program, including Health and Safety mandates and OSHA requirements.
• Complete other duties and responsibilities assigned by Senior Management.

Benefits

• Incentive compensation and equity may be included in total compensation in addition to base salary.
• CSL offers employee well-being benefits; details are available through the company benefits information.

What This Job Offers

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