Summary
The Sterility Assurance specialist provides technical expertise and support to the UK and Ireland Compounding Sites for all sterility assurance aspects. Acts as a valuable and effective source of information and advice on sterility assurance and positively contributes to the network Quality Management Team. Responsible for ensuring that the UK and Ireland Compounding Sites maintain a robust, effective and compliant sterility assurance and environmental control and monitoring process in conjunction with the global strategy.

Essential Duties and Responsibilities

• Responsible for ensuring effective Sterility Assurance and Environmental Monitoring programmes are deployed in UK and Ireland Compounding facilities, in compliance with current GMP and Baxter global strategy.
• Provide technical support and guidance on Sterility Assurance, Environmental Monitoring, environmental control, Contamination Control Strategy and aseptic practices across UK and Ireland Compounding facilities.
• Support risk management activities relating to Sterility Assurance, Environmental Monitoring, Contamination Control Strategy and aseptic practices, including support of site RTRA processes as required.
• Support the Global Compounding organization on standardisation of Sterility Assurance practices and identification and implementation of new technology for microbiological testing and environmental control
• Participation in continuous improvement projects and providing the expert guidance and assessment for the questions related with Sterility Assurance, including risk reduction initiatives in line with company strategy
• Provide coaching, mentoring and technical guidance to operational and quality teams in relation to Sterility Assurance, Environmental Monitoring, environmental control and aseptic practices.
• Provide technical oversight and interpretation of validation, qualification or study data related to Sterility Assurance, Environmental Monitoring, environmental control and aseptic practices, as required.
• Support inspection readiness and participate in internal, corporate and regulatory audits as the technical representative for Sterility Assurance, Environmental Monitoring, environmental control and aseptic practices, as required.
• Review and assess Environmental Monitoring reports and protocols to ensure compliance with regulatory standards and internationally acceptable standards.
• Support and lead problem solving investigations for product and process deviations or customer complaints.
• Participate in complaint investigation, non-conformance and quality incidents investigation, act as technical approver where required.
• Provide technical input to change controls where Sterility Assurance, Environmental Monitoring, Contamination Control Strategy, environmental control or aseptic practices may be impacted
• Provide technical support in the interpretation of microbial identification and Environmental Monitoring data, including trending of EM and microbiological data and setting of appropriate Alert limits
• Support Environmental Monitoring Management Software approval, configuration and reporting.
• Responsible for the tracking and reporting of Quality Metrics for internal and external use.
• Support the development and review of of quality documentation including local SOPs and documents related to Sterility Assurance, Environmental Monitoring, Contamination Control Strategy and aseptic practices, acting as document owner or Technical Approver as required.
• Provide microbiological expertise, training and operational guidance to operational and quality staff on Sterility Assurance, Environmental Monitoring, environmental control and aseptic practices, including periodic reassessment as required.
• Identify new, or changes to existing, processes and systems to improve effectiveness and efficiency of the Sterility Assurance programme whilst maintaining compliance with Corporate and Regulatory requirements.
• Adhere to Environmental Health & Safety (EHS) policies, procedures and requirements.
• Support maintenance of a safe place to work through escalation of unsafe EHS practices
• Maintain professional status and standards
• Fully support the Quality Policy and business goals and objectives by building quality into all aspects of work.
• Any other tasks from Sterility Assurance Manager.

Personal Profile and Attributes

• Team player with a collaborative attitude. Ability to build strong relationships with internal and external customers.
• Results oriented with excellent attention to detail
• Self-driven with strong motivation to achieve and exceed results and able to work independently as required
• Ability to prioritise work load and deliver against target, including under stressful conditions
• Positive and proactive approach to problem solving
• Strong interpersonal and communication skills with ability to work and communicate cross functionally within the Baxter Compounding cluster and wider Baxter network.
• Computer literate in standard MS Office applications such as Word Excel, PowerPoint Word, SharePoint, Office 365 for generation of reports, presentations, analysis of data etc.
• Knowledge of risk management tools and Lean Management principles

Education and Experience

• Degree in Microbiology, although other Life Sciences degrees may be considered with relevant experience
• Required 3 years’ experience in implementing environmental control programs and OOL investigation and correction
• Preferred 5 years’ experience of microbiology experience in an aseptic facility
• Strong operational experience preferably in an aseptic manufacturing background
• Experience of aseptic technique
• Excellent interpersonal skills
• Passionate advocate of quality as a discipline and continuous improvement
• Have experience in the use of quality improvement and problem solving skills (ie FMEA, DMAIC, Process Mapping etc) and the interpretation of data, experience of Lean manufacturing
• Have experience of critical equipment and process Change Control
• Able to work autonomously and take the initiative
• Demonstrate critical thinking and decision making, collaboration and teamwork, dealing with ambiguity, good management and communication skills, customer and patient focus

What are some of the benefits of working at Baxter?

• Competitive total compensation package
• Professional development opportunities
• High importance placed on work life balance

Baxter is an equal opportunity employer. Baxter evaluates qualified applicants without regard to race, color, religion, gender, national origin, age, sexual orientation, gender identity or expression, protected veteran status, disability/handicap status or any other legally protected characteristic.