CSV Analyst

Katalyst CRO; Durham (NC); On-site; USD 90,000 - 125,000; Full time

Job summary

Katalyst CRO seeks a qualified IT professional with GMP experience to support analytical lab IT systems and CS validation. You will analyze complex issues and translate lab processes into IT requirements, collaborating across diverse forums to implement effective solutions.

Responsibilities include leveraging Lab IT systems, prioritizing critical issues, and maintaining compliance with GXP standards while communicating clearly with stakeholders in a fast-paced environment.

Qualifications

• Prior work experience in pharma or other GMP setting.
• Strong working knowledge of analytical laboratory IT systems (Lab Vantage, Empower, Benching, Signals, L7, LabX, MODA, etc.).
• Solid knowledge of Computer System Validation process.
• Ability to analyse, anticipate, and resolve complex issues with sound problem-solving skills.
• Ability to prioritize and escalate issues.
• Learning agility and curiosity.
• Ability to translate analytical lab business processes into IT requirements/solutions.
• Strong communication across diverse forums.

Responsibilities

• Prior work experience in pharma or other GMP setting.
• Strong working knowledge of analytical laboratory IT systems (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

Lab IT systems

Computer System Validation

Problem solving

Escalation effectively

Learning agility

IT requirements gathering

Cross-functional communication

GMP/pharma experience

Education

Bachelor of Science (IT, Chemistry, Pharmacy, Science, Engineering)

Job description

• 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

Roles & 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

Requirements

• 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.
• Previous Agile experience.
• Professional experience working in a GXP regulated environment.