QA Systems Analyst

Quality System Analyst

Quality System Analyst is responsible for implementation, modification, maintenance, and oversight of Computer System Validation at the site. Responsibilities include initiation of applicable change controls and procedure updates to gain sample throughput efficiencies and ensure integrity of lab data via cGMP and Part 11 compliance.

Report to QA QMS Manager

Key Responsibilities

• Review electronic systems data and related documents to verify 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 proper configuration, validation, and change management of QA systems to comply with regulatory standards (FDA, ISO, GMP, etc).
• Collaborate with IT and software vendors to resolve system issues, implement updates, and optimize system functionality
• Identify, troubleshoot, and coordinate corrections regarding electronic systems or discrepancies.
• Initiate change controls as necessary to facilitate the implementation of electronic systems.
• Identify areas where training related to data electronic systems is needed and provide appropriate training as required to the site personnel.
• Support Regulatory filing data inquiries and enterprise/site system inspections
• Continually look for process improvement strategies
• Improve site awareness for data reliability related requirements, policies and procedures through reading of SOPs, guidelines and training.
• Identify compliance risks and escalate the issues to appropriate levels of management for resolution.
• Develop technical plans and analyze, identify, plan and manage the scope, and risks required to meet goals of moderately complex to complex projects.
• Develop and update SOPs, work instructions, and training materials for QA systems.
• Provide training and support to site personnel on system functionalities and best practices
• Generate and analyze quality system metrics, dashboards, and reports to support decision-making.
• Monitor system performance and recommend improvements.
• Perform other duties as required to fulfil department and business needs

Key Performance Indicators

• Demonstrate validation protocol are drafted and executed effectively.
• Deliver on assigned projects as scheduled.
• Support other departments on related projects as needed.

Skills and Experience - Familiarity with Good Manufacturing Practices (cGMP's) and Good Laboratory Practices (GLP).Experience with computer system validationExperience with change control practices and strategies.Familiarity with risk-based thinking or risk-based tools.Knowledge of equipment, facility, and utility IQ/OQ/PQ.Familiarity with various analytical equipment, techniques, and methodology.Excellent oral and written communicationExperience with MS Programs such as Word, Excel, PowerPoint, Access, Project etc. and proofreading skillsAbility to manage multiple priorities and re-prioritize tasks as required. Excellent problem-solving skills

Qualifications

Minimum Education: Bachelor’s degree in a Life Sciences, Chemistry or Computer ScienceMinimum of 3 years of relevant cGMP experience in the pharmaceutical/biotech industry

Additional Details

Work is performed in a typical office environment and manufacturing areas, with standard office equipment available and used. Work is generally performed seated but may require standing and walking for up to 20% of the time. Safety PPE is required when entering manufacturing and laboratory areas.