Quality systems specialist

Provides oversight for development and maintenance of quality programs, systems, processes and procedures to ensure compliance with company standards and regulatory guidelines. Support across the Quality Compliance organization including Quality Systems, Inspections, and Performance. This role will lead/facilitate deviation investigations, complaints, and issue resolution within QA compliance and CSL Contracted Manufacturing Operations (CMO). Drive Annual Product Quality Review (APQR) initiatives including contributing report timelines, executive summary creation, and issue escalations meeting required deadlines.

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.

The expected base salary range for this position at hiring is $76,000 - $95,000. Please note this salary range reflects the minimum and maximum base pay that CSL expects to pay for this position at the listed location as of the time of this posting. Individual base salary for a successful candidate is determined by qualifications, skill level, experience, competencies and other relevant factors. In addition to base salary, total compensation for this role may also include incentive compensation and equity.

Different qualifications or responsibilities may apply based on local legal and/or educational requirements. Refer to local job documentation where applicable.

About CSL Behring

CSL Behring is a global biotherapeutics leader driven by our promise to save lives. Focused on serving patients’ needs by using the latest technologies, we discover, develop and deliver innovative therapies for people living with conditions in the immunology, hematology, cardiovascular and metabolic, respiratory, and transplant therapeutic areas. We use three strategic scientific platforms of plasma fractionation, recombinant protein technology, and cell and gene therapy to support continued innovation and continually refine ways in which products can address unmet medical needs and help patients lead full lives.

CSL Behring operates one of the world’s largest plasma collection networks, CSL Plasma. Our parent company, CSL, headquartered in Melbourne, Australia, employs 32,000 people, and delivers its lifesaving therapies to people in more than 100 countries.

To learn more about CSL, CSL Behring, CSL Seqirus and CSL Vifor visit https://www.csl.com/ and CSL Plasma at https://www.cslplasma.com/.

Our Benefits

For more information on CSL benefits visit How CSL Supports Your Well-being | CSL.

You Belong at CSL

At CSL, Inclusion and Belonging is at the core of our mission and who we are. It fuels our innovation day in and day out. By celebrating our differences and creating a culture of curiosity and empathy, we are able to better understand and connect with our patients and donors, foster strong relationships with our stakeholders, and sustain a diverse workforce that will move our company and industry into the future.

To learn more about inclusion and belonging visit https://www.csl.com/careers/inclusion-and-belonging.

Equal Opportunity Employer

CSL is an Equal Opportunity Employer. If you are an individual with a disability and need a reasonable accommodation for any part of the application process, please visit https://www.csl.com/accessibility-statement.