Manufacturing Investigator - Specialist I/II/III (Manufacturing Quality Systems)

Job Purpose: 

Responsible for providing quality system support to Bulk manufacturing areas within the Seqirus Vaccines manufacturing facility located in Holly Springs, NC. Responsible for Deviations and investigations using Root Cause analysis and technical writing to complete reports for audit purposes.

*Level will be determined by years of experience

• 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.

• 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 skills

Our Benefits

Seqirus is committed to attracting and retaining world-class employees who are valued for their contributions to achieving business objectives. Learn more about some of the benefits you can participate in when you join Seqirus.

Seqirus is part of CSL Limited (ASX: CSL). As one of the largest influenza vaccine providers in the world, Seqirus is a major contributor to the prevention of influenza globally and a transcontinental partner in pandemic preparedness. Learn more about Seqirus.

As a global organisation with employees in 35+ countries, CSL embraces diversity, equity and inclusion. Learn more about Diversity, Equity & Inclusion at Seqirus.