We are seeking a highly skilled and detail-oriented Quality Assurance Data Analyst to join our esteemed pharmaceutical company based in Kentucky. As a Quality Assurance Data Analyst, you will play a crucial role in ensuring the accuracy, integrity, and compliance of our data systems and processes. Your expertise will contribute to maintaining our commitment to producing high-quality pharmaceutical products that meet regulatory requirements.
Data Analysis and Validation: Conduct thorough data analysis and validation to ensure accuracy, consistency, and integrity of data across various systems and databases. Identify and rectify any data discrepancies, errors, or anomalies.
Compliance Monitoring: Collaborate with cross-functional teams to develop and implement quality assurance strategies, processes, and tools to ensure compliance with regulatory standards, such as Good Manufacturing Practices (GMP) and Good Clinical Practices (GCP).
Quality Metrics Tracking: Establish and maintain key quality metrics and performance indicators to monitor the effectiveness of quality assurance initiatives. Analyze and report on quality trends, deviations, and risks to relevant stakeholders.
Documentation and Reporting: Prepare comprehensive and accurate reports, summaries, and documentation of quality assurance activities, including data analyses, audit findings, corrective and preventive actions (CAPAs), and process improvement recommendations.
Process Improvement: Identify areas for process improvement within quality assurance operations and develop innovative solutions to enhance efficiency, data accuracy, and compliance. Collaborate with teams to implement and monitor these improvements.
Data Management: Manage and maintain databases, ensuring the integrity, security, and availability of critical data. Implement data governance practices, including data validation, data cleansing, and data archiving.
Audits and Inspections: Support internal and external audits and inspections by providing accurate and timely data analysis, documentation, and evidence. Assist in developing responses and corrective action plans as required.
Training and Support: Provide training and support to employees on data management best practices, quality assurance processes, and tools. Foster a culture of data integrity and compliance throughout the organization.
- Bachelor's degree in a relevant field such as Data Science, Statistics, or Pharmaceutical Sciences. A master's degree is a plus.
- Proven experience as a Data Analyst or similar role within the pharmaceutical or healthcare industry.
- Strong knowledge of quality assurance principles, practices, and regulatory requirements.
- Proficient in data analysis and statistical techniques, using tools such as Excel, SQL, Python, or R.
- Familiarity with pharmaceutical data systems, electronic document management systems (EDMS), and enterprise resource planning (ERP) systems.
- Excellent attention to detail and analytical skills with the ability to interpret complex data sets and identify trends, risks, and opportunities.
- Solid understanding of GMP, GCP, and other relevant regulatory guidelines.
- Strong communication skills, both written and verbal, with the ability to present data and insights effectively to diverse audiences.
- Ability to work collaboratively in a team environment and effectively prioritize tasks to meet deadlines.
- Knowledge of data governance and data management best practices is desirable.
Join our dynamic and innovative team to make a meaningful impact on the quality and safety of pharmaceutical products. Apply today and be part of our mission to improve the health and well-being of patients worldwide.