- Quality Management
- Technical Writing
- Clinical Trials
JOB DESCRIPTION - SUMMARY
The Quality Assurance (QA) Associate is responsible for maintaining compliance with company policies, procedures, GCP regulations/guidelines and any other applicable requirements.This individual will also be responsible for executing audits (internal, vendor, investigational site), oversight of CAPAs, document creation, maintenance of the eQMS, and meeting the established quality goals of InClin.
- Experience with site audits required. Previous CTA or CRA experience at a CRO preferred
KNOWLEDGE & SKILLS REQUIREMENTS
- Broad knowledge of risk-based quality systems approaches consistent with ICH E6 for Good Clinical Practice required
- Robust knowledge of Good Clinical Practices (FDA and ICH) required
- Ability to identify and/or resolve quality issues/discrepancies with others in a proactive, diplomatic, flexible and constructive manner required
- Focused on detailed, clear and concise technical writing skills and strong oral communications required
- Demonstrated ability to work independently in a fast-paced, multi-project environment
- Ability to travel both domestic and internationally, as needed (expected travel up to 35%)
- Maintains a high regard for integrity, ethical conduct, and confidentiality in support of quality-based outcomes
The main responsibilities of this role include but are not limited to the following:
- Promote a culture of compliance and quality within InClin
- Plan, manage, and perform Quality Audits of investigator sites, essential documents, Trial Master Files, service providers, and internal processes.
- Manage to closure of Corrective and Preventive Action Plans
- Support, provide, and track training of InClin Personnel on SOPs, policies and GCP compliance, practices, and procedures.
- Provide effective management of systems and applications such as the electronic Quality Management System, Quality SmartSheet, and computer systems used by InClin.
- Ensure SOPs are updated regularly to maintain compliance with the InClin Quality Management Policy and current regulations
- Evaluate and communicate risks to critical trial processes and data with recommendations for mitigation to resolution.
EDUCATION AND EXPERIENCE REQUIREMENTS
- Bachelor’s degree or equivalent experience required (scientific or healthcare discipline preferred)
- Minimum of two (2) years’ experience in support of Clinical Quality Assurance/Clinical Development for a CRO or pharmaceutical/biotech company
- Clinical Quality experience in supporting all phases of clinical trials
- Experience with ZenQMS