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Specialist II, Manufacturing Quality Systems
Holly Springs, NC 27540 United States
Are you looking for a rewarding career in a market-leading and innovative company?
Seqirus is the new global company created from the combined strength and expertise of bioCSL and the influenza vaccines business formerly owned by Novartis. In July 2015, bioCSL and the influenza vaccines of Novartis joined forces to create what is now the second largest influenza vaccine company in the world. With extensive research and production expertise and manufacturing plants in the US, UK, Germany and Australia, Seqirus is a transcontinental partner in pandemic preparedness and a major contributor to the prevention and control of influenza globally.
Responsible for providing quality system execution and support to primary and secondary manufacturing areas in a Vaccines manufacturing facility located in Holly Springs, NC.
• Demonstrates strong working knowledge of deviation process and root cause analysis in order to own critical and complex major deviations. Writes Product Impact Assessments.
• Leads cross functional teams and performs deviation investigations for manufacturing using site procedures to ensure root cause is identified and appropriate corrective actions are put in place within 30 business days.
• Creates and executes CAPA plans to reduce the likelihood of reoccurrence.
• Owns and manages Level 0, Level I and Level II change controls.
• Writes Biological Product Deviation Report for submission to the FDA.
• May act as manufacturing owner of a quality system such as Deviation, CAPAs, Change Controls or Inspections. Responsibilities would include tracking and trending of system performance, mitigation of system risks, training of Specialists and allocation of resources.
• Performs Product Technical Compliant and Adverse Event investigations.
• Writes and submits customer complaints to vendors.
• Creates inspection ready plans. May present and defend Deviations, CAPAs and Change Controls to regulatory agencies.
• Provides technical support with unit operations. Identifies solutions to address technical problems.
• Writes technical training material for manufacturing processes.
• Provides support with multiple business process systems to support all areas of manufacturing. These systems include SAP, LIMS, Data Historian, and Sentry/Trackwise.
• Bachelor’s degree in Science or Engineering with 3+ years’ experience OR equivalent industry experience (pharmaceutical, biotechnology, and/or sterile production environments)
• 3+ years’ direct work experience with Deviations, CAPA’s and Change Controls
• Direct experience with cGMP environments required
• Advanced demonstration of deviation investigations and root cause analysis
• Advanced abilities in CAPA management and Change Controls
• Demonstrated troubleshooting skills
• Excellent organizational, planning and time management skills
• Strong oral, written and interpersonal communication skills
• Demonstrated leader within the department and in cross-functional teams
North Carolina Biotechnology Center