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Job Description
- Req#: ce6hsKZ32_zZXQS-AyteLg
Respon sible for assisting and leading the change control processes relevant to QC .
Represent QC as Subject Mat ter Expert (SME ) for planning change controls in all departments .
Lead change control site implementations.
Serve as backup to QC Investigation Owner.
Ensure QC's free dom to operate by maintaining compliance with all regulatory bodies and company regulations.
Participate in inter depa rtment al collaborations to plan change controls, investigate deviations, and review possible cGMP -related issues providing technical input as QC SME.
Drive continuous improvement within the QC department to ensure compliance with all regulatory codes.
Participate in auditing activities as needed for QC suppo rt.
Execute training /awareness related to cGMP change control s and investigations to QC personnel.
B.A. or B.S. degree p referabl y in a scientific field such as Ch emistry, Biology, Biochemistry, Biotechnology, Microbiology, or related fields .
3+ years of experience in the biotechnology or pharmaceutical indu stry or relevant quality organization.
Experience in GMP/GLP environ ments is desirable.
Technical writing experience is preferred.
Job Description
Overview:
This is an intermediate-level position in Quality Control Operations Support. The incumbent is responsible for providing the Quality Control (QC) Department support within the Quality Management Sy stem (QMS) . The main responsibilities of change c ontrol and deviation managemen t will drive continuous improveme nt in QC to ensure compliance with worldwide regulat ory requirements .
Key Responsibilities:
Education:
Experience:
Different qualifications or responsibilities may apply based on local legal and/or educational requirements. Refer to local job documentation where applicable.About Us
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.
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About the company
CSL Behring is a global biotherapeutics leader driven by its promise to save lives. Focused on serving patients’ needs by using the latest technologies, we develop and deliver innovative therapies. CSL is the parent company of CSL Behring.