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Specialist I/II/III, (Manufacturing Quality Systems) Fill Finish and Packaging areas

Employer
CSL Behring
Location
Holly Springs, North Carolina
Start date
Sep 27, 2021

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Job Details

With operations in 35+ nations and ~27,000 employees worldwide, CSL is driven to develop and deliver a broad range of lifesaving therapies to treat disorders such as hemophilia and primary immune deficiencies, and vaccines to prevent influenza. Our therapies are also used in cardiac surgery, organ transplantation and burn treatment.

CSL is the parent company of CSL Behring and Seqirus. CSL Behring is a global leader in the protein biotherapeutics industry, focused on bringing to market biotherapies used to treat serious and often rare conditions. CSL Behring operates CSL Plasma, one of the world's largest collectors of human plasma, which is used to create CSL’s therapies. Seqirus is one of the largest influenza vaccine companies in the world and is a transcontinental partner in pandemic preparedness and a major contributor to the prevention and control of influenza globally.

We invite you to take a look at the many career possibilities available around the globe and consider building your promising future at CSL by becoming a member of our team!

Job Description

Job Purpose:

Responsible for providing quality system support to Fill Finish and Packaging areas within the Seqirus Vaccines manufacturing facility located in Holly Springs, NC.

Major Accountabilities:
  • Owns deviations and writes product impact assessments.
  • Leads cross functional investigation teams in root cause analysis
  • Creates and executes CAPA plans to reduce the likelihood of reoccurrence.
  • Writes SOPs and batch records to support expansion activities
  • Issues SOPs and Batch Records to the production floor
  • Owns change controls including site wide change controls.
  • Writes Biological Product Deviation Report for submission to the FDA.
  • Performs Product Technical Compliant and Adverse Event investigations.
  • Provides technical support with multiple unit operations. Identifies solutions to address technical problems.
  • Writes technical training material for manufacturing processes.

Minimum Qualifications: 
  • Bachelor’s degree in Science or Engineering or equivalent industry experience required.
  • Minimum of 1 year of experience with deviation investigations, root cause analysis, CAPA management , and Change Controls
  • Direct experience within a cGMP environment
  • Demonstrated troubleshooting skills
  • Strong organizational, planning and time management skills
  • Strong oral, written and interpersonal communication skill

Company

As the third largest global biotechnology company with employees in more than 35 countries, CSL Behring is focused on serving patients with serious and rare diseases, including coagulation disorders, primary immune deficiencies, hereditary angioedema, respiratory disease and neurological disorders. We collaborate with patient and biomedical communities to improve access to therapies, advance scientific knowledge and support future medical research. 


CSL Behring's dynamic environment fosters innovation and attracts the best and brightest who share a commitment to helping save lives. People here are free to live their Promising FUTURES where they can fulfill their individual career aspirations and realize their potential. 


CSL Behring is committed to diversity and inclusion, both of which underpin our Values of patient focus, innovation, collaboration, integrity and superior performance. We believe that by harnessing and honoring the unique capabilities, experiences and perspectives of our people, we are better able to serve our patients.


CSL Behring operates one of the world's largest plasma collection networks, CSL Plasma. The parent company, CSL Limited, headquartered in Melbourne, Australia, employs more than 27,000 people, and provides its life-saving medicines in more than 70 countries. 
For more information visit www.cslbehring.com. Help us deliver on our promise to save lives and protect the health of people around the world. Promising FUTURES start at CSL Behring!

Stock Symbol: CSL

Stock Exchange: Australian Securities Exchange

Company info
Phone
610-878-4000
Location
1020 First Avenue
King of Prussia
Pennsylvania
19406
United States

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