QAO Specialist I
3.
1 Full-time 1 day ago Full Job Description QAO Specialist 1 The hours for this position are 12 hour shifts 6:
PM-6-AM (nights) including every other weekend.
The hours will equate to 40 weekly.
There is a nice differential for these shifts as well as overtime pay! QAO Specialist 1 Purpose:
This is an entry level position into Quality Assurance Operations.
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).
Experience:
0-2 years' experience working in a cGMP regulated environment such as the field of quality, manufacturing or engineering field, applying the cGMP rules in everyday activities.
Technical writing experience is preferred.
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.
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 As 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!.
Estimated Salary: $20 to $28 per hour based on qualifications.
1 Full-time 1 day ago Full Job Description QAO Specialist 1 The hours for this position are 12 hour shifts 6:
PM-6-AM (nights) including every other weekend.
The hours will equate to 40 weekly.
There is a nice differential for these shifts as well as overtime pay! QAO Specialist 1 Purpose:
This is an entry level position into Quality Assurance Operations.
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).
Experience:
0-2 years' experience working in a cGMP regulated environment such as the field of quality, manufacturing or engineering field, applying the cGMP rules in everyday activities.
Technical writing experience is preferred.
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.
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 As 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!.
Estimated Salary: $20 to $28 per hour based on qualifications.
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