QC Analyst Micro

Duties & Responsibilities

• Provide Microbiological support to the site
• Develop, maintain and update microbiological methods, specifications and SOP's in compliance with quality and regulatory requirements to allow the execution of the analysis in a GMP environment. This will include trending data, monitoring Out of Specifications and participating in laboratory investigations.
• Testing of In-process, Drug Substance and Drug Product Batches manufactured.
• Co-ordinating all site Utilities testing-environmental monitoring and water testing programmes.
• Lead all environmental investigations, root cause analysis, and report close out.
• Lead monthly environmental review meetings and present all relevant trends to a cross departmental team.
• Provide annual contamination control training to all personnel. Provide aseptic technique training to all new employees.
• Validation of microbiological methods e.g. bioburden and endotoxin.
• Support autoclave validation programme.
• Stability testing of Drug Substance and Drug Product Batches
• Participate in Quality and Safety regulatory audits.
• Support raw material testing when required for GMP manufacture
• Input into the identification of equipment requirements and work with vendors to ensure execution of all deliverables, including equipment qualification and validation.
• Troubleshooting equipment and techniques within the Analytical team.
• Participation in other projects/duties as defined by the Quality Director

POSITION SPECIFICATION

Qualifications, Experience, Skills, Knowledge and Attributes

• Third level degree in a life Science discipline
• 2-5 years’ experience in a microbiology role with relevant experience in environmental monitoring and utilities testing, bioburden testing and endotoxin testing. Experience in validation of microbiological methods also required.
• Strong analytical and technical skills
• Ability to learn quickly and take responsibility for tasks/projects.
• Highly organised and structured approach to task completion.
• Strong time management awareness and the ability to drive projects forward.
• Excellent verbal and written communication skills, including ability to present work in clear, concise reports or presentations.

Full time

Regular

Colleague

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