Specialist II QA Operations
Company: CSL
Location: Kankakee
Posted on: January 22, 2023
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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
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