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Sr. Specialist, QC (Validation)
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.
To manage and perform validation activities in support of the QC organization. These activities consist of developing and authoring validation protocols and reports, authoring analytical methods, analytical method transfers, and development of assay training. Strong knowledge of Analytical chemistry or biochemistry validation in order to be a subject matter expert during agency audits and technical troubleshooting in QC laboratories. Ensure that QC laboratories perform validation activities in compliance with cGMP and ICH Guidelines. Collaborate with TD and other partners to deliver robust method for use in routine QC testing activities.
• Author and Track Execution of method validations and transfers in accordance to internal SOPs and ICH Guidelines.
• Act as Subject matter expert for agency audits and internal investigations
• Assist manager with planning and tracking of validation/transfer activities according to schedule
• Author/own QC methods
• Collaborate with TD and other partners to deliver robust methods for the execution in QC for release of Flu vaccine product samples and Raw materials.
• Perform analytical method validation reassessments
• Complies with policies and procedures in order to maintain compliance with legal regulations, health and safety, and regulatory requirements as written
• Train and mentor junior level staff in validation/transfer requirements
• Plan and own reports for control qualifications to ensure that they are readily available to QC testing laboratories
• Plan and execute the annual strain change activities for cell based assays.
• Coordinate and plan day to day QC validation activities with QC Testing management to agreed upon schedule.
• Review assay data and trend assay performance as applicable
• Bachelor’s degree in Biochemistry or Chemistry OR equivalent scientific degree
• Minimum of 8 years working in GMP Laboratory environment with a minimum of 3-5 years of experience performing validations for Biochemistry or Chemistry
• Ideal candidates will additionally have proven project leadership for several validation/transfer projects to defined timelines
• Working knowledge of compendial requirements (USP and EP)
• Advance Experience in method validation per ICH and transfers with working knowledge of method development
o Experience with for validations specifically for Bioanalytical assay preferred however analytical validation experience is acceptable.
o Knowledge & awareness of current industry issues & evolving trends in the regulated environment; both domestically & internationally.
o Demonstrated effective communication skills both written and verbal with a focus on collaboration and group problem solving.
o Strong interpersonal, communication, negotiation, multitasking and problem solving skills.
North Carolina Biotechnology Center