Sterility Assurance Specialist (12 Month Fixed-Term Contract)

Under direction from the Senior Sterility Assurance Site Lead, this role is to provide sterility assurance support and training for the Seqirus Liverpool site as well as all third-party manufacturing facilities that perform manufacturing activities on behalf of Liverpool.  

Ensures that from an aseptic perspective, the day to day manufacturing operation runs in accordance with its validated status, all SOPs, the Quality manual and Good Manufacturing Practice. Responsible for authoring and owning Environmental Monitoring trend reports, owning and facilitating aseptic training and gowning qualification, and assisting in manufacturing investigations due to microbiological excursions, such as out of specification results, objectionable organism recoveries and breaches of the sterile boundary. 

Associate is responsible for working closely with the manufacturing area managers to identify adverse trends and establishing and implementing corrective actions.

Responsibilities

• Under general supervision, provides support on Quality systems to ensure compliance with company standards and GMP regulatory guidelines
• Responsible for authoring Environmental Monitoring trend reports with detailed analysis and interpretation of the data. Ensures that all of the operational areas are also fully aware of results obtained and trends that are developing and ensuring that they have the opportunity to contribute to root cause investigations.
• Develops, maintains and improves GMP-related gowning qualification programs including standard operating procedures (SOPs)
• Supports quality systems related to Validation, Deviation Management, CAPA, Change Control, and Enterprise Learning Management
• Collects, collates, evaluates, and reports on Environmental Monitoring performance data of assigned business areas
• Participates in internal and external audits and assists with 3rd party supplier audits; implements continuous improvement projects
• Collaborates to resolve technical sterility assurance issues, provide aseptic training and communicate best practices

Education

• Bachelor degree in a relevant scientific discipline (Chemistry, Biology, Microbiology, etc.) or Engineering.

Experience

• 3-5 years' quality systems experience in pharmaceutical manufacturing/cGMP regulated environment
• Experience of aseptic processes and sterility assurance preferred
• Knowledge of current Good Manufacturing Practices (cGMP)
• Knowledge of FDA and EMA requirements

This position is available as a 12-month secondment opportunity.