What are the responsibilities and job description for the Validation Analyst (IQ, OQ, PQ) position at ALTA IT Services, LLC?
VALIDATION ANALYST (IQ, OQ,PQ)
US CITIZENSHIP REQUIRED
100% REMOTE
HOURLY RATE: $40/HR range. W2, Benefits Available
ALTA IT Services has a contract opening for a Validation Analyst to join our client in a 100% remote role supporting EST work hours. This is a 6 month project.
Duties and Responsibilities:
US CITIZENSHIP REQUIRED
100% REMOTE
HOURLY RATE: $40/HR range. W2, Benefits Available
ALTA IT Services has a contract opening for a Validation Analyst to join our client in a 100% remote role supporting EST work hours. This is a 6 month project.
Duties and Responsibilities:
- Develop and execute validation protocols (IQ, OQ, PQ) for equipment, systems, or processes.
- Perform risk assessments and define validation strategies based on system impact.
- Document validation activities following regulatory standards (e.g., FDA, EMA, GxP, 21 CFR Part 11).
- Collaborate with cross-functional teams (QA, IT, Manufacturing, Engineering) to gather requirements and ensure validation readiness.
- Support audits and inspections by providing validation documentation and responses.
- Maintain validation lifecycle documentation, including validation plans, reports, deviations, and change controls.
- Track and manage validation deliverables and timelines for projects.
- Stay current with industry best practices and regulatory changes
Required Skills/Certifications:- Bachelor’s degree in Life Sciences, Engineering, Computer Science, or related field.
- Experience in validation (equipment, process, software, or computer systems).
- Familiarity with regulatory guidelines (GxP, 21 CFR Part 11, Annex 11, etc.).
- Strong analytical, documentation, and problem-solving skills.
- Attention to detail and ability to manage multiple validation projects.
- Excellent communication and organizational skills
Preferred Skills/Certifications:- Experience with computerized system validation (CSV).
- Knowledge of validation in regulated environments (e.g., pharmaceutical, biotech, medical devices).
- Proficiency in validation tools and documentation software.
- Relevant certifications (e.g., ISPE, ASQ, or CSV certifications).
Min Citizenship Status Required: US Citizen
Location: Remote, US (EST)
HOURLY RATE: $40/HR range. W2, Benefits Available
Ref: #855-IT Baltimore
- Experience with computerized system validation (CSV).
- Bachelor’s degree in Life Sciences, Engineering, Computer Science, or related field.
Salary : $40