Senior Sterility Assurance Specialist - CSL : Job Details
Senior Sterility Assurance Specialist
CSLJob Location : Holly Springs,NC, USA
Do you want to work with a company that tackles fascinating problems and find solutions to complex challenges? Seqirus has an exciting opportunity to join our expanding team in Holly Springs, NC. With an advanced manufacturing facility and expertise in influenza science we are one of the world leaders in the production of the influenza vaccine. We operate as one integrated global company, drawing together expert staff from different countries to collaborate. Together, we're working on the front line to protect communities from seasonal influenza and global pandemic threats. When you join Seqirus, you join a team dedicated to making a difference in people's lives. It's a feeling of possibility, creativity, and purpose that inspires us every day.You will work onsite in our Holly Springs, NC location and will report to the Site or Regional Lead of Sterility Assurance, Senior Sterility Assurance Specialist will be responsible under general direction to provide support on Quality systems to ensure compliance with company standards and GMP regulatory guidelines. Benefits Include flexible hours M-F, Onsite Café, Medical, Dental, Vision, Life Insurance, 401K, and PTO available from your first day of hire.Responsibilities
- Provide CSL Enterprise Sterility Assurance Specialist guidance to a local team at your manufacturing sites.
- Provide strategic leadership to the site engineering, validation, operations and quality functions related to sterility assurance.
- Work collaboratively with the local SA, quality and manufacturing teams to provide a holistic contamination control strategy and improvement plan at the CSL Enterprise Manufacturing site.
- Collaborate with internal and external partners for the design of best practice sterility assurance controls for the microbial contamination control strategy and life cycle management - to deliver on time and to the required standards and regulatory requirements concerning validation activities affecting sterile manufacturing (Fill / Finish area incl. filling, lyophilizes, sterilizers, isolator technology and auxiliary equipment, personnel training and qualification, cleaning and disinfection programs etc.).
- Use knowledge of the facility, process and equipment to design the validation / qualification controls on an aseptic facility in the field of expertise and accountability.
- Use knowledge of the facility, process and equipment to design the microbiological controls of the aseptic facility in the field of expertise and accountability.
- Lead local and global project teams as a sterility assurance representative in the improvement of processes, systems, and the standardization of workflows and processes within the your responsibilities
- Escalate emerging trends and/or changes in performance of accountability and in regulatory guidance to local stakeholders to ensure that all the operational areas are fully aware of results obtained and trends that are developing and ensuring that they have the opportunity to contribute to root cause investigations.
- Ensure that global standards are met for best practice
- Bachelor's degree in a related discipline (Microbiology, Biochemistry, Pharmaceutical Sciences). Advanced degree (Masters/Ph.D.)
- 3+ years experience providing technical and personal support and ability to work collaboratively and pragmatically with others to ensure successful outcomes.
- Demonstrated ability for conceptual and analytical thinking within a production environment
- In-depth knowledge of cGMP's, FDA, TGA, EU and other relevant GxP regulations including current knowledge of industry best practice with respect to sterility assurance principals
- Experience working with international teams