What are the responsibilities and job description for the Quality System Specialist position at GForce Life Sciences?
Quality Systems Specialist
Our client is seeking a Quality Systems Specialist to support Quality Management System (QMS) processes, ensuring compliance with internal procedures and regulatory requirements.
- This is a 12-month contract with the possibility of extension.
- The role is primarily remote, but candidates in the Rockville, MD, or Princeton, NJ areas are preferred for one day per week on-site presence.
Key Responsibilities:
- Review Quality Systems (QS) records in Trackwise to ensure completeness and compliance with internal procedures and applicable regulatory requirements.
- Monitor and track on-time closure of QS records, ensuring timely follow-up.
- Serve as the point of contact for QS record extension request justifications.
- Identify trends, emerging risks, and compliance gaps to elevate to management.
- Support root-cause analysis and provide investigation guidance.
- Collaboratively review and approve internal QS procedures.
- Serve as reviewer, approver, or owner of deviations, CAPAs, change control, or investigations.
- Review change control records for compliance, including impact analysis, risk assessment, and action item completion.
- Oversee QS performance monitoring using statistical methods and drive process improvements.
- Facilitate quarterly site metrics review meetings and assist in audits and inspections.
- Provide support and interface with vendors regarding investigations and root cause analysis reports.
Qualifications & Experience:
- Bachelor’s degree in science (engineering degree preferred).
- 5 years of experience in medical devices, combination products, device development, GMP manufacturing, or quality.
- Strong understanding of 21 CFR Part 820 and Part 4 requirements (preferred).
Required Skills:
- Proficiency in electronic Quality Management Systems (Trackwise).
- Knowledge of cGMP/GxP principles, Quality Management Systems, and global regulatory requirements.
- Experience using electronic document management systems, MS Office, and project management tools.
