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.

Any unsolicited resumes sent to Zoetis from a third party, such as an Agency recruiter, including unsolicited resumes sent to a Zoetis mailing address, fax machine or email address, directly to Zoetis employees, or to Zoetis resume database will be considered Zoetis property. Zoetis will NOT pay a fee for any placement resulting from the receipt of an unsolicited resume.

Zoetis will consider any candidate for whom an Agency has submitted an unsolicited resume to have been referred by the Agency free of any charges or fees. This includes any Agency that is an approved/engaged vendor but does not have the appropriate approvals to be engaged on a search.