Investigation Owner

This role is responsible for leading investigations to ensure the written investigation report contains the technical merit and completeness according to regulatory expectations. This position will be responsible for operating cross-functionally, collecting necessary data and information associated with the manufacturing and laboratory deviations. This position will lead root cause analysis sessions with site SME’s and determine the associated corrective action to prevent the deviation from recurring. This person will be a key player in the Operations Services team and a champion for quality priority principles and compliance within the Operations organization. This position reports directly to the Operation Services Manager responsible for deviation investigation management.

Responsibilities:

• Develops a comprehensive understanding of the manufacturing processes followed for CSL products and the associated risk management control strategy developed to identify process risks and associated critical controls around the associate processing steps.
• 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 Manufacturing and Quality teams.
• Collaborates with other leaders across the organization and assists in the continuous improvement and life cycle management of implemented GMP policies and quality management systems.
• The investigation owner will lead the investigation of deviations that occur in operations.     Author and manage the investigations to meet key timing commitments, with well-investigated and well-documented deviation reports.
• Partners with quality assurance, quality control, operations, engineering, maintenance, calibration, safety and supplier quality management to ensure appropriate and timely determination of scope, product impact, root cause and corrective actions.
• Determines scope, product impact, root cause and corrective actions for deviations from procedures. Proposes and implements effective CAPA to eliminate these causes.

Qualifications:

• University degree in a relevant scientific discipline (Pharmacy, Chemistry, Biology, Biochemistry)
• 3+ years of technical writing experience, writing deviations and CAPAs in the pharmaceutical/biotech industry
• Experience with deviation or investigation management systems.
• Ability to author and review standard operating procedures, on-the-job-trainings, and other controlled documents.
• Ability to put complex thoughts and issues into writing in such a manner that an educated, but uninformed reader can understand and make decisions based on the written investigation report.

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

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 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 .

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