Clinical IT Quality Control Analyst

This is a fully remote position, open to applicants in North Carolina, +1 more state.

📋 Description

• Supervise the quality control and assurance processes for software, ensuring the integrity of processes and data validation.

• Offer guidance and support to operational teams to maintain compliance with GxP, 21 CFR Part 11, and relevant regulatory standards.

• Collaborate with Global Quality and Education, IT QC Specialists, Validation Specialists, Business Owners, Product Owners, and Product Analysts.

• Assist research operations and IT in understanding corporate and regulatory requirements concerning software validation, quality management, and GxP.

• Manage quality-related activities associated with software, process, and data integrity validation.

• Evaluate validation lifecycle documents, which include validation assessments, 21 CFR Part 11 assessments, system validation plans, risk management plans, and validation summary reports.

• Provide quality direction through the preparation, execution, data analysis, and report writing for IQ, OQ, and PQ protocols.

• Support the periodic review of system documentation.

• Conduct quality reviews of changes affecting validated systems and/or processes.

• Perform additional tasks as assigned.

⛳️ Requirements

• A Bachelor's Degree is required; professional experience may be accepted in lieu of education.

• Hands-on experience in a QA/QC role focused on computerized systems validation.

• Experience in the GCP clinical environment, such as with CROs or SMOs, is highly preferred.

• A minimum of 3 years of professional experience in clinical research, biotech, or pharmaceutical settings, with an emphasis on FDA GxP requirements for systems, 21 CFR Part 11, and FDA software validation guidelines.

• Familiarity with EU regulations, such as Annex 11, is preferred.

• Understanding of industry and international software quality standards, including GAMP V, PIC/S, and ICH.

• Knowledge of 21 CFR Part 11 requirements and software validation principles applicable to pharmaceuticals, biologics, CROs, and clinical sites.

• Must reside in the United States.

• Visa sponsorship is not available.

🏝️ Benefits

• Extensive benefits that promote physical, mental, and financial wellness.

• Competitive salary package.

• Opportunities for annual bonuses or long-term incentives may be available.

• Equity options may be part of the compensation.

• Relocation assistance is not provided.

• Visa sponsorship is not available.