Specialist I/ II/III Manufacturing Quality Systems

Employer
CSL Behring
Location
Holly Springs, North Carolina
Posted
Oct 30, 2020
Ref
R-124467
Required Education
Bachelors Degree
Position Type
Full time
About CSL

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 primary and secondary manufacturing 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
• Direct experience within a cGMP environment preferred
• Experience with deviation investigations and root cause analysis preferred
• Experience with CAPA management and Change Controls preferred
• Demonstrated troubleshooting skills
• Strong organizational, planning and time management skills
• Strong oral, written and interpersonal communication skills