Quality Systems Specialist

Responsibilities

• Under general supervision, maintains Quality Assurance System to ensure compliance with company and cGMP standards
• Site APQR coordinator, collaborates with SMEs to author APQR contributing reports for each product produced at Kankakee and is responsible for authoring the associated executive summary report.
• Provides and maintains local APQR/Deviation processes, updating SOPs or associated official documents as required.
• Responsible for leading the investigation of deviations that are identified by Compliance, as well as deviations entered by the site CMO. Author and manage the investigations to meet key timing commitments, with well-investigated and well-documented deviation reports. Provides consistent direction and ensures timely completion of deviation investigations to ensure on-going consistency for investigation reports that will stand alone during regulatory inspection through close collaboration with all necessary teams.
• Assists QA Systems Lead in identifying potential deviation/incident issues with process/system and communicating with Compliance.
• Foster a culture of continuous improvement through employee selection, training and mentoring while focusing on operational efficiency and the elimination of “non-value added” activities.
• Participate/Lead in Self-Inspections, Internal Audits, and Regulatory Inspections, identifying improvements for the facility through the process
• Complies with requirements from CSL Behring’s Safety Program, including Health and Safety mandates and OSHA requirements.
• Completes any other duties/responsibilities assigned by Senior Management.

Qualifications

Education

• B.A. or B.S. degree, preferably in a scientific or technical field (e.g., chemistry, biology, physics, engineering, computer science, technical writing). In lieu of the above, equivalent work experience and/or knowledge gained will be considered.

Experience

• 3+ years’ experience working in a cGMP regulated environment such as the field of quality, manufacturing or engineering field, applying the cGMP rules in everyday activities. Technical writing experience required. In lieu of the above, a proven ability to perform in this role will be considered.