Summary:
This position will assist in the ongoing conduct of the organization’s quality program, ensuring the organization remains in compliance with Standard Operating Procedures, Good Clinical Practices (GCP) and applicable regulatory requirements. The primary goal is to conduct sampling, tests, audits and analyses of trends and root cause, and educate to bring about improvements in all parts of the organization.
Job Duties:
- Design, implement and document quality program procedures
- Maintain a working knowledge of Standard Operating Procedures, Federal Regulations, Guidance Documents, and accreditation standards for human research subject’s protection
- Contribute to the creation and development of Standard Operating Procedures for the company as necessary
- Continually review requirements related to new processes, new service introduction and changes in technology and customer needs; Verify and validate whether processes meet specified requirements
- Initiate and participate in cross-functional problem solving projects; Establish and maintain records of quality improvement practices
- Coordinate and conduct internal system audits; Collect, analyze and report data and information from a variety of processes and teams
- Coordinate, conduct, track, and resolve company-wide Corrective/Preventative Actions investigations; Monitor the implementation of those actions
- Analyze overall findings for trends and key process failures, providing input for training regarding identified quality trends
- Work collaboratively with clients and Schulman staff to identify and lead the implementation of continuous improvement efforts and support strategic initiatives
- Assist the QA Director in providing feedback on quality findings to individuals, teams and managers
- Contribute and assist in ongoing management reporting of quality issues, trends, risks and losses
- Coordinate, conduct, and track regulatory training (ICH/GCP/ 21 CFR parts 50, 56 and 11, 45 CFR 46); Develop training materials and applicable tests and guides
- Represent the organization in matters related to quality, compliance and process consistency
- Facilitate external quality audits and regulatory audits of Schulman; Facilitate and conduct on-site audits of research sites and service providers of Schulman, as directed
- All other duties as assigned
Skills and Qualifications:
- Working knowledge of Federal regulations for human research (21 CFR 50, 56, 312, and 812; and 45 CFR 46)
- Ability to identify and resolve problems in a timely manner
- Ability to exercise sound judgment and initiative in collection of information from a wide variety of sources
- Knowledge of inspection and quality control methods, techniques and documentation
- Ability to work with complex or diverse information and data
- Excellent organizational skills, managing conflicting demands and priorities, without compromising quality
- Demonstrates accuracy and thoroughness
- Ability to work independently; effectively balances team and individual responsibilities
- Contributes to building a positive team environment by supporting individual efforts to success
- Ability to develop and lead educational programs designed for both groups and individuals
- Effectively and professionally communicate with all levels of staff, including high level reporting to management
- Excellent written and verbal communication skills including ability to develop a consensus and drive others to achieve quality goals
- Ability to utilize common software such as Word, Excel, Access, PowerPoint, SharePoint; ability to learn new software as required and remain proficient in all programs necessary to perform duties of this position
Education and Experience:
- Bachelor’s Degree with at least three (3) years in data or software quality role At least two years’ experience in quality improvement, quality control, quality management systems, compliance and/or utilization management