Clinical IT Quality Control Analyst

This is a fully remote position, open to applicants in Tennessee.

📋 Description

• Manage the quality control and assurance processes for software, as well as ensure the integrity of processes and data validation.

• Offer guidance and support to operational teams regarding GxP, 21 CFR Part 11, and other regulatory mandates.

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

• Aid research operations and IT in understanding corporate and regulatory guidelines.

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

• Supply quality guidance for the preparation, execution, data analysis, and report writing related to IQ, OQ, and PQ protocols.

• Assist with the periodic review of system documentation.

• Conduct quality reviews of changes that impact validated systems and processes.

• Perform additional duties as assigned.

⛳️ Requirements

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

• Proven experience in a QA/QC role within computerized systems validation.

• A minimum of 3 years of professional experience in a clinical research, biotech, or pharmaceutical setting, emphasizing FDA GxP requirements for systems, 21 CFR Part 11, and FDA software validation guidelines.

• Experience in the GCP clinical space, such as working with a CRO or SMO, is highly preferred.

• Familiarity with EU regulations, including Annex 11, is preferred.

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

• Knowledge of pharmaceutical, biologics, CRO, and clinical site 21 CFR Part 11 requirements and software validation principles.

• Candidates must reside in the US.

• Relocation assistance and visa sponsorship are not available.

🏝️ Benefits

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

• Competitive compensation package.

• Potential annual bonuses or long-term incentive opportunities.

• Access to resources and opportunities for personal growth and development.

• Support for maintaining a balanced lifestyle.