Senior Auditor (Job Code: EF0417)

DUTIES:

Perform quality systems audits of approved and/or potential suppliers of raw materials, components, suppliers, contract manufacturers (CMO), distributors and service providers for CSL Sites. May also perform local site audits, as requested. Perform remote and paper-audits assigned per fiscal year. Prepare audit report and assign levels of compliance to each observe action based on established criteria. Deliver audit results to suppliers in a professional manner. Evaluate supplier corrective action plans are satisfactorily addressing the observation(s). Responsible for interpreting and making decisions based on company policies/procedures, regulatory agencies, local, state, federal and international regulations. Responsible for supplier quality agreements, global and local, which include writing, editing, reviewing, updating, and routing the agreements for approvals between CSL Manufacturing Site, service providers and suppliers. Assist the Manufacturing Site as the subject matter expert for Supplier Quality during inspections to mitigate compliance risk to the manufacturing site and to Supplier Quality. In collaboration with Global Sourcing, support supplier development and ongoing positive relationships with the external quality functions within CSL's Critical Suppliers. Attend local deviation review meetings and acts as liaison between Supplier and Local Site to assist deviation investigation processes. Participate in change control process on supplier and material changes. In collaboration with Assoc. Director/Sr. Manager, External Supply Quality, develop individual development plan which cultivates individual and organizational bench-strength. Up to 60% domestic and international travel required.

REQUIREMENTS:

Bachelor’s degree (or foreign equivalent) in Pharmaceutical Engineering, Industrial Engineering, or related field plus 5 years of experience in the offered position or related position.

SPECIAL REQUIREMENTS:

Must possess expertise/knowledge sufficient to adequately perform the duties of the job being offered. Expertise/knowledge may be gained through employment experience or education. Such expertise/knowledge cannot be “quantified” by “time”. Required expertise/knowledge includes:

• Experience with GxP environment in the pharmaceutical industry.

• Understanding of required regulations, including FDA, PiC/S and European regulation, Therapeutics Goods Authority, and Canadian Health Authority.

• Auditing knowledge and experiences within the pharmaceutical industry.

• Experience working in a global, matrix organization.

• Process Improvement Techniques (Six Sigma, Lean).

• Risk Management Tools (FMEA).

• Quality and Problem-solving tools (Pareto charts, Cause and effect diagrams, statistical processes, Root cause analysis).

• Experience applying the requirements of Quality Management Standards (ISO 9000, ISO 13485).

• Supply Chain Management knowledge.

• Industry knowledge in Blood Plasma Therapies.

OTHER: Job Site: Bradley, IL. 40 hours/week. Salary range: $80,101 per year to $90,935 per year. If offered employment must have legal right to work in U.S. EOE.

CONTACT: CSL Behring LLC, Attn: Tonetta Parker, 1020 First Avenue, King of Prussia, PA 19406 (Reference Job Code: EF0417)

This notice is being provided as a result of the filing of a permanent alien labor certification application for this job opportunity. Any person may provide documentary evidence bearing on the application to: Certifying Officer, U.S. Department of Labor, Employment and Training Administration, Office of Foreign Labor Certification, 200 Constitution Avenue, NW, Room N-5311, Washington, DC 20210

This position is eligible for CSL Behring LLC’s Employee Referral Program.

CSL employees that work at least 30 hours per week are eligible for benefits effective day 1. We are committed to the wellbeing of our employees and their loved ones. CSL offers resources and benefits, from health care to financial protection, so you can focus on doing work that matters. Our benefits are designed to support the needs of our employees at every stage of their life. Whether you are considering starting a family, need help paying for emergency back up care or summer camp, looking for mental health resources, planning for your financial future, or supporting your favorite charity with a matching contribution, CSL has many benefits to help achieve your goals.

Please take the time to review our benefits site to see what’s available to you as a CSL employee.

CSL Behring is a global leader in developing and delivering high-quality medicines that treat people with rare and serious diseases. Our treatments offer promise for people in more than 100 countries living with conditions in the immunology, hematology, cardiovascular and metabolic, respiratory, and transplant therapeutic areas. Learn more about CSL Behring.

As a global organization with employees in 35+ countries, CSL embraces diversity and inclusion. Learn more about Diversity & Inclusion at CSL.