Quality Control Specialist

Rockville, MD
Full Time
Mid Level
Welcome! At Digital Infuzion, we believe that everyone deserves to live a better, healthier life. That's why we're dedicated to providing life science researchers with faster insights and health providers with on-demand data and tailored software solutions. Our passion for developing innovative healthcare solutions goes beyond ordinary health IT services to include comprehensive translational research support. If you're looking for a creative, open, and growth-oriented environment where you can do what you love while helping people live healthier lives, then keep scrolling - we may have just the opportunity for you. 

Career Opportunity 
Are you ready to play a vital role in ensuring the accuracy and reliability of clinical research data? We are looking for a Quality Control Specialist to join our team. In this role, you will work closely with the quality control lead, clinical data analysts, and project managers to monitor and validate data quality throughout the project lifecycle. You will be responsible for implementing quality control measures that ensure compliance with regulatory standards and internal protocols. If you have a keen eye for detail and a passion for ensuring data accuracy, we invite you to apply for this exciting opportunity.

Position Overview 
The Quality Control Specialist will play a key role in ensuring that clinical research data and project deliverables meet the highest quality standards. You will be responsible for reviewing, validating, and auditing data to ensure accuracy, consistency, and completeness. Additionally, you will work with cross-functional teams to implement quality control procedures that align with regulatory guidelines and best practices. The ideal candidate has experience in quality control within clinical research or healthcare and a strong understanding of data validation techniques.

Responsibilities  
  • Data Quality Monitoring: Monitor and validate the accuracy, completeness, and consistency of clinical research data and project deliverables.
  • Quality Audits: Conduct regular audits of data, reports, and project documentation to ensure compliance with quality control standards and regulatory requirements.
  • Compliance with Regulatory Standards: Ensure all data and processes comply with regulatory guidelines, including FDA, GCP, and other clinical research regulations.
  • Collaboration with Teams: Work closely with project managers, clinical researchers, and data analysts to identify and address data quality issues and ensure that corrective actions are implemented.
  • Process Improvement: Assist in the development and implementation of quality control processes and procedures to improve data integrity and project outcomes.
  • Documentation: Maintain accurate records of quality control activities, audits, and corrective actions, and prepare reports for internal and external stakeholders.

Requirements
  • Bachelor’s Degree in a related field (e.g., Life Sciences, Health Informatics, Quality Management) or equivalent experience.
  • Proven experience as a Quality Control Specialist or in a similar role within clinical research, healthcare, or life sciences.
  • Strong understanding of quality control principles and data validation techniques.
  • Familiarity with regulatory guidelines (e.g., FDA, GCP) and compliance standards in clinical research.
  • Excellent organizational skills with attention to detail and the ability to manage multiple tasks.
  • Strong communication and collaboration skills to work effectively with cross-functional teams.
  • Ability to analyze data and identify discrepancies, trends, and areas for improvement.
  • Experience with clinical data management systems (CDMS) and electronic data capture (EDC) systems.
  • Knowledge of data validation tools and quality management software.
  • Experience conducting quality audits and preparing reports for regulatory bodies.

Digital Infuzion, LLC is an Equal Opportunity Employer. EOE/AA/M/F/D/V  
Digital Infuzion, LLC’s policy is to provide equal employment opportunities without regard to race, color, religion, sex, gender identity, sexual orientation, national origin, age, disability, marital status, veteran status, genetic information, or any other protected characteristic under applicable law. 
 
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