Bulk 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.

Main Responsibilities and Accountabilities:

• 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.

• Determines appropriate preventative actions to prevent reoccurrence of the deviation, authors deviations and conducts personnel interviews to determine the root cause of the deviation.

• Update SOPs or other official documents as required.

• 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.

• Provide a positive and equitable working environment emphasizing the CSL Values: Customer Focus,

• Innovation, Integrity, Collaboration, and Superior Performance.

• 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.

Position Qualifications and Experience Requirements:

• Bachelor’s Degree in Engineering, Pharmaceutical Technology, Chemistry, Pharmacy or equivalent scientific degree

• 3+ years of experience in a cGMP regulated manufacturing Pharmaceutical environment and/or QA/QC, preferred.

• 3+ years of technical writing experience, writing deviations and CAPAs in the pharmaceutical/biotech industry

• Experience with deviation or investigation management systems.

• Relevant industry Biotechnology Manufacturing and/or Quality operations experience.

• 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

• Proficient in Deviation Management (i.e. TrackWise).

• Experienced in troubleshooting, investigation, and root-cause analysis in a cGMP environment.

• Proficient in the use of the following methodology: 5-WHY, Fish-bone diagram, Is and Is-Not, Root Cause Analysis, Human Error Reduction.

Our Benefits

We encourage you to make your well-being a priority. It’s important and so are you. Learn more about how we care at CSL.

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 organisation with employees in 35+ countries, CSL embraces diversity, equity and inclusion. Learn more about Diversity, Equity & Inclusion at CSL.