Sr. Clinical QA Specialist
Greater Boston area
Looking to elevate your career to the next level with one of the hottest Immuno-Oncology companies in the Boston area? We have partnered with one of the most exciting IO companies in its search for a newly created Sr. Clinical QA Specialist. This company has one of the most robust pipelines you can have given their stage of development. As a small testament to this companies promise, they just had their initial public offering last month and generate double the expected revenue from entering the stock market! There is a clear path for growth in this position and given that every employee is awarded stock it can be an incredibly lucrative opportunity as well.
The Sr. Clinical QA Specialist will have the following responsibilities:
- Assist in the development and implementation of GCP quality standards, policies, and procedures that comply with applicable standards, regulations and guidelines for GCP globally.
- Perform compliance review of clinical protocols, clinical study reports, investigator brochures and other clinical documentation
- Assist with coordination and logistics for pre- and post-inspection and audit activities, including training, and functional area readiness
- Assist with developing storyboards, along with functional areas and subject matter experts to be shared during audits for key processes and programs.
- Work cross functionally to build and maintain inspection readiness content to ensure quick access to materials in the event of an inspection or audit
- Represent CQA as single point of contact to assigned study teams including attending cross-functional study team meetings.
- Manager GCP vendor, clinical site and TMF audits related to assigned study teams including tracking all findings, responses, CAPAs, etc.
- Assist with implementation and maintenance of Electronic Document Management Systems. Assist with drafting processes and procedures to support EDMS.
- Perform a variety of tasks, duties and responsibilities as assigned from time to time
Ideal Candidates will have:
- 2 years of GCP Experience (Ideally in a QA position)
- Also open to individuals with GCP experience with non-QA background so long as they have worked in quality for at least 1 year.