19063 – Quality Control Specialist – Carlow Contractor

Purpose

To provide technical support to the QC Microbiology Lab & operations to ensure the continued manufacture and supply of quality pharmaceutical products in meeting the priorities of: Compliance, Supply, Strategy and Profit Plan. This role holds more senior responsibilities within the Microbiology Laboratory including (but not limited to) documentation development, report writing, execution of method and equipment validation, drug product result authorization, providing microbiological support for site, performance of bench experiments as required. The ideal candidate will be capable of self-management and decision making and will demonstrate a high level of leadership, initiative, collaboration, and coaching to facilitate the team in becoming a high performance organization. Central to this objective will be the active engagement and
communication with all internal (e.g. QC Analytical, Tech Ops, IPT, QA) and external (e.g. Microbiology COE). A high level of innovation, enthusiasm and drive will be required to deliver technical excellence in required for this role.

Responsibilities

• Development and execution of Microbiology test methods, Method Validation and Method Qualification, mainly bioburden, endotoxin and Sterility test methods.

• Troubleshooting of issues which arise during the execution of validation studies and routine tests.

• Development of training modules.

• Microbiology Support to Site Investigations

• Driving Continuous Improvement initiatives, including lean lab initiatives, method optimization/redevelopment.

• Authoring and managing change controls, procedures, test methods and deviations.

• Result authorization for microbiological samples to support batch release.

• LIMS System updates

• Assessing compendial and quality manual updates pertaining to the Microbiology Lab & environmental control.

• Supporting lab stock management and financial control as required.

• Supporting the environmental control program by trend analysis and implementation of appropriate corrective and preventative measures.

• Understands and applies regulatory / compliance and compendial requirements to their role together with remaining current on upcoming regulatory and compliance changes.

• Interprets customer needs, assesses requirements and identifies solutions to nonstandard requests.

• Makes decisions within guidelines and policies which impact microbiology projects.

• Ensure highest safety standards.

• May be required to perform other duties as assigned.

Requirements

• Bachelor’s Degree or higher preferred; ideally in Microbiology or a closely related discipline.

• Knowledge and experience in interpreting current applicable regulatory requirements and providing independent support to the site.

• Strong knowledge in the area of method development including experiment design to ensure robust validation data.

• Demonstrated ability to work independently and fully realize improvement initiatives with minimal guidance.

• Demonstrated ability to drive the completion of tasks.

• Demonstrated delivery of SME knowledge above site.

• Demonstrated successes in a team environment, such as project teams, Six Sigma team etc.

• Advanced PC skills such as Excel, Word, PowerPoint.

• Demonstrated ability to clarify, communicate and solve complex problems.

• Highly motivated and interested in bringing current microbiology research and technology platforms toward a biopharmaceutical operations application