What are the responsibilities and job description for the Quality Assurance Systems Specialist / Senior Specialist & Site Data Integrity Lead position at Rang Technologies Inc?
Position Overview
We are seeking an experienced Quality Assurance Systems Specialist / Senior Specialist & Site Data Integrity Lead to support quality assurance, validation, qualification, and data integrity initiatives within a pharmaceutical or biotechnology environment.
Key Responsibilities
- Support commissioning, qualification, and computerized system validation (CSV) projects.
- Write, execute, review, and approve validation protocols, reports, and system lifecycle documentation.
- Collaborate with QA, QC, IT, Automation, and vendors on qualification and validation activities.
- Conduct change control, risk assessments, and data integrity gap assessments.
- Provide subject matter expertise in validation strategy and compliance.
- Support troubleshooting, investigations, root cause analysis, and CAPA activities.
- Promote site-wide Data Integrity (DI) awareness and continuous improvement.
- Establish and facilitate Data Integrity forums, remediation reviews, and regular DI GEMBA walkthroughs.
- Support client and regulatory inspections and employee training.
Required Qualifications
- Bachelor’s degree in a scientific discipline or related field.
- Minimum 5 years of experience in pharmaceutical, biotechnology, or a related industry, including at least 2 years in a Quality Unit.
- Experience with equipment and analytical instrument qualification and computerized system validation.
- Working knowledge of GxP requirements, 21 CFR Part 11, EU Annex 11, and relevant USP standards.
- Knowledge of validation documentation, change control, risk management, investigations, and CAPA.
- Strong understanding of Data Integrity principles and regulatory compliance.
“We are an equal opportunity employer. It is our policy to provide employment, compensation, and other benefits related to employment without regard to race, color, religion, sex, gender, national or ethnic origin, disability, veteran status, age, genetic information, citizenship, or any other basis prohibited by applicable federal, state, or local law.”
Salary : $45 - $50