Senior Quality Specialist
The Senior Quality Specialist is responsible for supporting the maintenance of the corporate Quality Management System (QMS) that promotes customer satisfaction and company improvement. The Senior Quality Specialist initiates and implements quality improvement activities as appropriate to raise performance of the company services. In addition, the Senior Quality Specialist independently carries out QMS improvement and maintenance activities as assigned.
Summary of Essential Job Functions
- Support maintenance of company Quality Management System
- Maintaining company Quality Management System (QMS) documents and artifacts.
- Managing and coordinating internal audits and supporting client audits
- Supporting client audits
- Maintaining company-wide quality and SDLC document templates
- Coordinating QMS training efforts and training others on DrugDev LMS System
- Building strong relationships with internal clients, providing quality management support
- Coordinating the company-wide Corrective and Preventive Actions (CAPA) program
- Facilitating the CAPA process and Investigations
- Supporting quality management related internal project team meetings and calls
- Supporting project teams during quality management related sponsor meetings and calls
- Other duties as assigned
- Strong interpersonal and communication skills (both written and verbal).
- Understanding of clinical trials.
- Knowledge and experience with 21CFR Part 11 and GXP.
- Self-starter with the ability to work in a global team environment.
- Ability to carryout quality management activities independently.
- Orientation toward accomplishing strategic business goals.
- Ability to handle multiple priorities.
- Detail- and results-oriented with a focus on quality.
- Proficiency with MS Word, Excel, and PowerPoint.
Minimum Experience Requirements
- Either a Bachelor Degree in business or science OR at least 3 years of relevant work experience
- Experience with business processes and document management and development
- Strong PC skills (i.e. Microsoft Office)
- Comfortable working in a small company environment
- Proven organization skills
Great people know great people. Who’s in your network? If you know someone who would thrive at DrugDev TrialNetworks, refer them to us for a $1500 referral bonus – for you or for the charity of your choice. Please contact Adrian Mendoza to make a referral.
Location: Boston MA