Overview
QA IT Validation Specialist Jobs in Albany, NY at United Pharma Technologies Inc
Title: QA IT Validation Specialist
Company: United Pharma Technologies Inc
Location: Albany, NY
Job Title: QA IT Validation Specialist
Location: Albany, NY
Job Summary:
We are seeking a skilled QAIT Validation Specialist to support IT Quality and Data Integrity initiatives within a regulated environment. This role acts as a Subject Matter Expert (SME) in supporting investigations, risk assessments, and IT operations, ensuring GxP computerized systems continue to operate as intended post-validation. The consultant will work cross-functionally to help develop and enforce policies that ensure compliance with regulatory standards.
Key Responsibilities:
Collaborate with IT teams to ensure compliance with internal Quality System requirements.
Apply Quality Risk Management (QRM) principles in both formal and informal assessments.
Support and guide activities related to change controls, CAPAs, deviations, audits, SOPs, and data integrity.
Assist with internal/external IT audits and support vendor qualification efforts.
Contribute to Quality Assurance Agreements (QAAs) and Approved Supplier List (ASL) processes.
Partner with stakeholders to maintain compliance throughout the Quality Management System (QMS) lifecycle.
Ensure alignment of systems/processes with SOPs, WIs, and regulatory guidelines.
Assist in resolving inspection-related issues concerning software systems and data integrity.
Required Experience & Qualifications:
7+ years of experience in IT, Computer Science, Engineering, or Chemistry within an FDA-regulated manufacturing environment.
In-depth understanding of Computer System Validation (CSV) and QAIT responsibilities in a GxP context.
Solid experience with risk-based validation practices.
Strong knowledge of FDA 21 CFRs, Eudralex, and other global pharma regulations.
Expertise in Data Integrity, SDLC, and software quality requirements.
Proficient in root cause analysis and risk management methodologies.
Hands-on experience with quality management systems (change control, deviation, incident management).
Proven project management skills, leading cross-functional validation efforts.
Strong technical writing, communication, analytical, and problem-solving skills.
Continuous improvement mindset with a focus on optimizing performance and compliance.
