At QualityHub, we have experience in staff augmentation for several types of companies and roles. Here are four examples of staff augmentation case studies to give you some background on that experience.
Overcoming Staffing Issues to Gain Compliance
Read the complete case study here.
Multiple Roles – Consent Decree
Staff Augmentation Case Study
For a client under a consent decree, we provided manpower to work within the quality organization due to a lack of personnel on the client end. These projects were six months to over a year. The positions we filled on a temporary basis were:
- Acting/Interim Quality Manager
- Acting/Interim Complaints Manager
- Acting/Interim CAPA Manager
- Acting/Interim Sustaining Engineering Manager
Quality Manager – Warning Letter
Staff Augmentation Case Study
For a client under a warning letter, we provided an acting/interim quality manager. This person managed the day-to-day quality organization as well as the efforts to address the warning letter and prepare for an FDA reinspection. The duration of the project was over 18 months. For this project, the client was so happy with the individual they asked if he could serve as acting/interim vice president of quality.
Senior Advisor – Warning Letter
Staff Augmentation Case Study
For a client under several warning letters, we provided an acting/interim quality management system senior advisor who provided two specific scopes of work over a 12-month duration:
- Served as the corporate-level project architect for a company-wide risk management program
- Served as a coach to an incoming corporate quality vice president
Audit Program Manager – Medical Device
Staff Augmentation Case Study
For a medical device client, we provided an individual who served for over six months as an acting/interim internal audit program manager. This individual also performed several audits in numerous countries while serving in this capacity.
