Quality Assurance Specialist
PRIMARY OBJECTIVE OF THE POSITION:
The primary objective of the QA Specialist position is to provide support to the QA Department in overseeing quality systems compliance for clinical operations and drug development activities of the company. This is to be achieved by ensuring that all the company’s quality systems (employee training, internal audits, vendor management, SOPs, and deviation management) are being maintained as appropriate and in a timely manner.
The ideal candidate will have a Bachelor’s degree and three to five years of experience in clinical research, quality assurance, and/or QA compliance. The qualified candidate should possess a strong knowledge of Good Clinical Practices (FDA and ICH), a good understanding of 21CFR Part 11 with respect to clinical processes and systems, and the ability to identify and/or resolve quality issues/discrepancies with others in a proactive, diplomatic, flexible and constructive manner. Some GLP (Good Laboratory Practices) and GMP (Good Manufacturing Practices) experience is also highly desirable. Attention to detail as well as a clear and concise style in written and oral communications is required.
MAJOR RESPONSIBILITIES AND DUTIES:
The responsibilities of the QA Specialist include:
- Assist in maintaining an effective Quality Management System to support internal and external audits of drug and clinical development-related study records to assure compliance with regulatory requirements and company SOPs.
- Assist in conducting client audits, investigator Site audits, database audits, TMF audits, in-house clinical file audits, and review of clinical study reports.
- Assist in developing, maintaining and managing company policies, SOPs and associated processes and procedures; this will include a “needs assessment” of company policies and procedures.
- Maintain records of employee training on policies, SOPs, and associated processes and procedures using TI’s Learning Management System (Compliance Wire).
- Assist in the development of strategies for QA projects and programs.
- Work with the QA Department head and various other department heads to identify, improve, and resolve quality-related issues as identified via audit findings, SOP reviews, rework, etc.
- Provide support to the QA Department as requested by the department head.
- Develop a mindset of needing continuous training (SOPS, FDA regulations, ICH guidelines, industry seminars, etc.) to better serve the company in this role.