Overview
Quality Assurance Specialist – Pharma Jobs in Pomona, CA at Intellectt Inc
Title: Quality Assurance Specialist – Pharma
Company: Intellectt Inc
Location: Pomona, CA
Role: Quality System Analyst – Pharma/Biotech
Location: Pomona, CA
Duration: 12+ Months – Onsite
Responsible for implementing, maintaining, and overseeing Computer System Validation (CSV) to ensure lab data integrity, cGMP compliance, and Part 11 adherence.
Key Responsibilities
Review electronic system data for compliance with 21 CFR Part 11 and data integrity standards.
Draft and execute validation documents (URS, FRS, Risk Assessment, IQ/OQ/PQ, Validation Summary Report).
Ensure proper configuration, validation, and change management of QA systems.
Collaborate with IT and vendors to resolve issues, implement updates, and optimize functionality.
Identify, troubleshoot, and coordinate resolution of system discrepancies.
Initiate change controls for electronic system implementations.
Provide training on system use and data reliability requirements.
Support regulatory filings, inspections, and data inquiries.
Develop and update SOPs, work instructions, and training materials.
Generate and analyze system metrics for decision-making.
Identify and escalate compliance risks.
Drive process improvement initiatives.
Key Performance Indicators
Effective drafting and execution of validation protocols.
Timely delivery of assigned projects.
Cross-functional support on related projects.
Skills & Experience
Knowledge of cGMP, GLP, and computer system validation.
Experience with change control and risk-based approaches.
Familiarity with equipment, facility, and utility IQ/OQ/PQ.
Strong problem-solving and communication skills.
Proficiency in MS Office (Word, Excel, PowerPoint, Access, Project).
Ability to manage multiple priorities efficiently.
Qualifications
Education: Bachelor’s degree in Life Sciences, Chemistry, or Computer Science.
Experience: Minimum 3 years of relevant cGMP experience in the pharmaceutical/biotech industry.
