Specialist II QA Operations

Company: CSL
Location: Kankakee
Posted on: January 22, 2023

Job Description:

Specialist ll QA OperationsPosition Purpose:Developing responsibilities include assisting with investigating deviations, relevant to area of responsibility. Responsible for driving continuous improvement on production floor to ensure compliance to cGMPs. Real time review of batch records, including critical processing steps with production floor presence.Responsibilities:Responsible for assisting with investigating deviations relevant to area of responsibility. Responsible for participating in investigation meetings with responsible department and any required support group(s).Responsible for participating in necessary research to determine root cause, corrective/preventative actions, product disposition, and using the investigation tools provided by QAO Management.Collaborate with manufacturing personnel to perform root cause analysis at time deviation occurs and assist in determining robust corrective/preventive actions.On-call for immediate inspections, investigations, and review of possible GMP related issues and ability to provide quality assessment of potential deviation.Responsible for real-time review of critical in-process steps (e.g. viral reduction / sterility assurance), review/approval of completed production records, and providing immediate notification to manufacturing personnel (e.g. supervisors/operators) regarding facility/process /equipment /documentation issues.Execute training/awareness related to investigation and GMP changes to production personnel.Drive continuous improvement on production floor to ensure compliance to cGMPs.As appropriate to area of responsibility, responsible for ensuring sample retain area is maintained in a state of compliance and all annual inspections are completed in a timely manner.As appropriate to area of responsibility, perform Acceptable Quality Level (AQL) assessments.Education:B.A. or B.S. degree preferably in scientific or technical field (e.g., chemistry, biology, physics, engineering, computer science, technical writing).Qualifications3+ years' GMP experience in pharmaceutical/biotech or other regulated industry.Knowledge of current Good Manufacturing Practices (cGMP) principles.Knowledge of FDA and EMA requirements.Competencies:Informing - is timely and accurate with information.Peer Relationships - Can quickly find common ground and solve problems for the good of all, is a team player and cooperative.Self-Knowledge - Seeks feedback, gains insights from mistakes, is open to criticism.Action Oriented - Enjoys working hard; is energetic for the things that he/she sees as challenging.Written Communications - is able to write clearly in a variety of communication settings and styles, can get messages acrossConflict Management - Steps up to conflicts, seeing them as opportunities, can find common ground.Learning on the Fly - Open to change, learns quickly when facing new problems, versatile learner.Dealing with Ambiguity - Can effectively cope with change, can shift gears comfortably, can comfortably handle risk and ambiguity.Additional Competencies:Must demonstrate competency in verbal and written communication. TrackWise knowledge a plus.Our BenefitsWe encourage you to make your well-being a priority. It's important and so are you. Learn more about how we care at CSL.About CSL BehringCSL 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 usAs a global organization with employees in 35+ countries, CSL embraces diversity and inclusion. Learn more about Diversity & Inclusion at CSL.Do work that matters at CSL Behring!

Keywords: CSL, Joliet , Specialist II QA Operations, Other , Kankakee, Illinois