Note: The job is a remote job and is open to candidates in USA. Katalyst CRO is a company specializing in clinical research services, and they are seeking a CSV Analyst. The role involves working with analytical laboratory IT systems and ensuring compliance with Computer System Validation processes.
Responsibilities
- Prior work experience working in pharma or other GMP setting
- Strong working knowledge of analytical laboratory IT systems (i.e. Lab Vantage, Empower, Benching, Signals, L7, LabX, MODA, etc.)
- Solid knowledge of Computer System Validation process
- Demonstrated ability to analyse, anticipate, and resolve complex issues through sound problem-solving skills
- Effectively prioritize and escalate issues
- Demonstrated learning agility and curiosity
- Demonstrated ability to understand analytical lab business processes and convert into IT requirements/solutions
- Desire and ability to communicate using a variety of methods in diverse forums
Skills
- Prior work experience working in pharma or other GMP setting
- Strong working knowledge of analytical laboratory IT systems (i.e. Lab Vantage, Empower, Benching, Signals, L7, LabX, MODA, etc.)
- Solid knowledge of Computer System Validation process
- Demonstrated ability to analyse, anticipate, and resolve complex issues through sound problem-solving skills
- Effectively prioritize and escalate issues
- Demonstrated learning agility and curiosity
- Demonstrated ability to understand analytical lab business processes and convert into IT requirements/solutions
- Desire and ability to communicate using a variety of methods in diverse forums
- Bachelor of Science degree in IT, Chemistry, Pharmacy, Science, Engineering, or related field
- At least 3 years of relevant work experience in information technology, engineering, computer system validation, quality control support or related areas
- Professional experience working in a GXP regulated environment
- Previous Agile experience
Benefits
- Work model: remote, onsite
Company Overview