Company: CSL Behring
Posted on: November 22, 2021
About CSLWith operations in 35+ nations and -27,000 employees
worldwide, CSL is driven to develop and deliver a broad range of
lifesaving therapies to treat disorders such as hemophilia and
primary immune deficiencies, and vaccines to prevent influenza. Our
therapies are also used in cardiac surgery, organ transplantation
and burn treatment.CSL is the parent company of CSL Behring and
Seqirus. CSL Behring is a global leader in the protein
biotherapeutics industry, focused on bringing to market
biotherapies used to treat serious and often rare conditions. CSL
Behring operates CSL Plasma, one of the world's largest collectors
of human plasma, which is used to create CSL---s therapies. Seqirus
is one of the largest influenza vaccine companies in the world and
is a transcontinental partner in pandemic preparedness and a major
contributor to the prevention and control of influenza globally.We
invite you to take a look at the many career possibilities
available around the globe and consider building your promising
future at CSL by becoming a member of our team!Job DescriptionThis
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
- 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
- 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
- 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
- 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---
- 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
- 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
- Relevant industry Biotechnology Manufacturing and/or Quality
- 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 Systems (i.e.
- 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
- Action Oriented
- Communicates Effectively
- Decision Quality
- Drives Results
- Balances Stakeholders
- Instills Trust
- Organizational Savvy
Keywords: CSL Behring, Joliet , Investigation Owner, Other , Kankakee, Illinois
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