What are the responsibilities and job description for the QA Systems Analyst position at DMV IT Service?
Job Title: Quality System Analyst
Location: Pomona, CA
Employment Type: Full-Time
About Us:
DMV IT Service LLC is a trusted IT consulting firm, established in 2020. We specialize in optimizing IT infrastructure, providing expert guidance, and supporting workforce needs with top-tier staffing services. Our expertise spans system administration, cybersecurity, networking, and IT operations. We empower our clients to achieve their technology goals with a client-focused approach that includes online training and job placements, fostering long-term IT success.
Job Purpose:
The Quality System Analyst is responsible for the implementation, modification, maintenance, and oversight of Computer System Validation at the site. This role ensures sample throughput efficiencies and the integrity of lab data compliance with cGMP and Part 11.
- Review electronic systems data and related documents for compliance with data integrity and 21 CFR Part 11 requirements.
- Draft and execute computer system validation documents including URS, FRS, Risk Assessment, Design Specification, IQ/OQ/PQ, and Validation Summary Report.
- Ensure QA systems are configured, validated, and managed correctly to comply with regulatory standards (FDA, ISO, GMP, etc.).
- Collaborate with IT and software vendors to optimize system functionality and resolve issues.
- Initiate change controls as necessary for electronic systems implementation.
- Identify and coordinate corrections for discrepancies in electronic systems.
- Develop and update SOPs, work instructions, and training materials.
- Provide training on system functionalities and compliance requirements.
- Support regulatory filing data inquiries and inspections.
Key Performance Indicators:
- Effective drafting and execution of validation protocols.
- Timely delivery on assigned projects.
- Proactive support to other departments on related projects.
Skills and Experience:
- Familiarity with cGMP and GLP.
- Proven experience with computer system validation and change control practices.
- Knowledge of risk-based tools and equipment, facility, and utility IQ/OQ/PQ.
- Strong proficiency in MS Office applications.
- Excellent communication, problem-solving, and prioritization skills.
Qualifications:
- Bachelor’s degree in Life Sciences, Chemistry, or Computer Science.
- Minimum of 3 years relevant cGMP experience in the pharmaceutical or biotech industry.
Additional Details:
- Work environment: Typical office setting with periodic visits to manufacturing and laboratory areas.
- Physical requirements: Mostly seated but may require up to 20% time standing or walking.
- Safety PPE required in manufacturing and laboratory areas.
