IT Quality Systems Specialist

Purpose
The IT-QA Associate is responsible for the accurate review and oversight of electronic laboratory and equipment data to ensure data integrity, compliance, and traceability. This role provides documented evidence of system-related activities and events that may impact product quality, in alignment with cGMP and regulatory requirements.

Job Summary
The IT-QA Associate is an individual contributor and a key member of the Pharmaceuticals Quality Team. This role monitors and evaluates electronic records, audit trails, and system changes to ensure compliance with 21 CFR Part 11 and other applicable regulations. The position supports quality investigations, CAPA activities, and continuous improvement initiatives related to electronic data systems. The role reports directly to the Site Quality Head.

Key Responsibilities

• Serve as a Subject Matter Expert (SME) for IT-related activities supporting Quality Management System (QMS) platforms and other regulated electronic systems requiring compliance with 21 CFR Part 11.
• Monitor and review audit trails and electronic records to identify irregularities, unauthorized changes, or trends that could impact data integrity or product quality.
• Perform routine analysis of electronic data to proactively identify risks, trends, and opportunities for process improvement.
• Provide training to laboratory and manufacturing personnel on the proper use of digital platforms supporting GMP and GLP activities, with emphasis on audit trail integrity, data integrity, and cGMP compliance.
• Support investigations related to electronic data issues and participate in the development and implementation of corrective and preventive actions (CAPAs).
• Collaborate cross-functionally with Quality, IT, Laboratory, and Manufacturing teams to ensure compliant system use and documentation practices.

Education and Experience Qualifications

• Bachelor's degree (B.Sc.) in a scientific discipline related to the pharmaceutical industry (e.g., Biology, Chemistry, Pharmacology, Biochemistry).
• Minimum of two (2) years of Quality Assurance experience in a GMP-regulated pharmaceutical manufacturing environment, supporting Quality Control Laboratory and Manufacturing Operations.
• Working knowledge of quality systems related to electronic data generation, storage, retrieval, archival, and audit is required.
• Experience with MDI or DPI dosage form manufacturing is preferred.

Knowledge, Skills, and Abilities

• Strong understanding of current Good Manufacturing Practices (cGMP).
• Experience reviewing electronic records and audit trails in regulated systems.
• Aptitude for quantitative problem-solving, data analysis, and advanced analytics.
• Experience writing and executing performance or system-related tests.
• Strong database, computer, and data visualization skills.
• Advanced proficiency in Microsoft Excel.
• Excellent attention to detail with the ability to prioritize and manage multiple tasks under strict deadlines.
• Self-motivated, proactive, and capable of working independently with minimal supervision.
• Strong organizational, written, verbal, and presentation communication skills.

Additional Information

• On-site position; no remote work available.
• Relocation assistance may be negotiable.
• No employment sponsorship available.

**Nesco Resource offers a comprehensive benefits package for our associates, which includes a MEC (Minimum Essential Coverage) plan that encompasses Medical, Vision, Dental, 401K, and EAP (Employee Assistance Program) services.

Nesco Resource provides equal employment opportunities to all employees and applicants for employment and prohibits discrimination and harassment of any type without regard to race, color, religion, age, sex, national origin, disability status, genetics, protected veteran status, sexual orientation, gender identity or expression, or any other characteristic protected by federal, state, or local laws.**