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.
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.
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- 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.
Qualifications
Education:
BA or BS Degree preferably in the scientific or technical field. (e.g., Chemistry, Biology, Engineering, Computer Science).
OR
GED/High School Diploma with a minimum of 8 Years of Pharmaceutical Industry Experience.
Experience:
- 3+ years of Manufacturing Experience, Pharmaceutical environment and/or QA/QC preferred.
- Significant technical experience in:
Change Management
Change Control
CAPA
Root Cause Analysis
- Knowledge of cGMPs and FDA guidelines required
- Demonstrated ability to multi-task while maintaining efficiency within processes and project timelines.
- Technical writing experience, specializing in drafting deviation investigations and developing Corrective Action and Preventative Action (CAPA) plans preferred.
The expected base salary range for this position at hiring is $71,000 - $90,000. 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.
Our Benefits
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.
About CSL Behring
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.
We want CSL to reflect the world around us
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. Learn more Inclusion and Belonging | CSL.
Do work that matters at CSL Behring!