Specialist I/II/III, Manufacturing Quality Systems (Fill Finish Expansion)
Company: CSL Behring
Location: Holly Springs
Posted on: November 19, 2021
About UsWith 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 DescriptionJob
Purpose: Responsible for providing quality system support to Fill
Finish manufacturing areas within the Seqirus Vaccines
manufacturing facility located in Holly Springs, NC.Major
- Owns deviations and writes product impact assessments.
- Leads cross functional investigation teams in root cause
- Creates and executes CAPA plans to reduce the likelihood of
- Writes SOPs and batch records to support expansion
- 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
- Performs Product Technical Compliant and Adverse Event
- Provides technical support with multiple unit operations.
Identifies solutions to address technical problems.
- Writes technical training material for manufacturing
- Bachelor's degree in Science or Engineering or equivalent
industry experience required.
- Minimum of 1 years of experience with deviation investigations,
root cause analysis, CAPA management , and Change Controls or
equivalent experience in the pharmaceutical industry.
- Direct experience within a cGMP environment
- Demonstrated troubleshooting skills
- Strong organizational, planning and time management skills
- Strong oral, written and interpersonal communication
Keywords: CSL Behring, Cary , Specialist I/II/III, Manufacturing Quality Systems (Fill Finish Expansion), Other , Holly Springs, North Carolina
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