Overview
CSV Analyst Entry Level Jobs in United States at United Consulting Hub
Title: CSV Analyst Entry Level
Company: United Consulting Hub
Location: United States
Job Title: CSV Analyst Entry Level
Job Type: Contract
Location: Remote
Experience: 1–2 Years
Job Summary:
We are looking for an Entry-Level CSV Analyst to support the validation of computerized systems in pharmaceutical and life sciences environments, ensuring compliance with GMP, GAMP 5, and 21 CFR Part 11 requirements.
Key Responsibilities:
- Support the validation of computerized systems, including LIMS, ERP, MES, SCADA, and other GxP applications.
- Assist in preparing, reviewing, and executing validation documentation, including:
- User Requirements Specifications (URS)
- Participate in validation planning, risk assessments, and traceability activities.
- Ensure compliance with Good Manufacturing Practices (GMP), GAMP 5, 21 CFR Part 11, and applicable GxP regulations.
- Maintain validation documentation in accordance with Good Documentation Practices (GDP).
- Support change control, deviation investigations, CAPA, and periodic review activities.
- Assist during internal and external audits and regulatory inspections.
- Collaborate with Quality Assurance (QA), Information Technology (IT), Engineering, and business stakeholders throughout the system validation lifecycle.
- Promote data integrity by ensuring adherence to ALCOA+ principles and regulatory expectations.
Required Skills:
- Basic knowledge of CSV lifecycle and validation documentation.
- Understanding of GMP, GAMP 5, 21 CFR Part 11, and data integrity.
- Strong documentation, analytical, and communication skills.
- Familiarity with LIMS, SAP, MES, or SCADA is a plus.
- Bachelor's degree in Life Sciences, Pharmacy, Biotechnology, IT, Engineering, or a related field.
