Based in Cork, our client is a global pharmaceutical company focused on developing first-in-class and best-in-class therapeutics that provide meaningful advances to patients who live with serious and life-threatening rare genetic diseases.
They require a Sterility Analyst with a minimum of 1 years’ experience in a Sterility Test Lab/ sterility assurance testing, to join them, initially on a 12-month contract (maternity leave cover). The role will cover Microbiological testing, including but not limited to microbiological method verification and B&F testing in the sterility test suite.
Job Reference: BBBH 21557
What will a Sterility Analyst do?
- Support for sterility testing including EM, utilities testing, BI, growth promotion, ID’s.
- Perform primary review of QC raw data and trend results.
- Prepare protocols, summaries, and reports—often for direct submission to pharmaceutical regulatory agencies.
- Draft QC SOPs.
- Act as technical resource (SME)and train other analysts in areas of expertise.
- Evaluate results against defined acceptance criteria.
- Conduct and document laboratory investigations to completion.
- Maintain the laboratory in an inspection-ready state.
- Interact directly with regulatory agency inspectors during audits.
- Interface with other BioMarin departments (Manufacturing, Quality Assurance, Facilities, etc.) and contractors as necessary.
What does the Ideal Candidate look like?
- Min 1 years’ experience in a Sterility Test Lab/ sterility assurance testing.
- Degree in Microbiology or related field.
- Sterility experience
- Ability to work independently and meeting established timelines.
- Comfort with coordinating the activities with other staff members.
- Comfort with working in a team environment
- Knowledge of cGMPs.
- 20 days annual leave (pro-rata) plus paid bank holidays. Competitive Salary.
- Flexibility for working from home.
- State of the art modern office.
- Work Laptop, phone (most roles), and latest tools and technologies.
- Expanding workforce with options for permanent positions and career progression for top performers.
- The experience of working with a company that will make your CV stand out from the crowd.
Still interested in this opportunity?
Submit your CV (in a Microsoft Word format) today!
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