Quality Associate

A remote Quality Associate opportunity is available on a 12-month contract, supporting clinical studies within the pharmaceutical, biotechnology, medical device, or CRO industry. The role provides quality oversight across multiple clinical trials from study start-up through closeout.

Key Responsibilities:

• Partner with clinical and cross-functional teams to support the planning, execution, monitoring, and reporting of clinical trials.
• Review quality metrics, operational data, and performance trends to identify risks, compliance issues, and process improvement opportunities.
• Assess protocol deviations, data integrity concerns, quality events, and noncompliance issues, escalating findings as needed.
• Support CAPA effectiveness reviews, audit and inspection follow-up activities, and risk-based quality management initiatives.
• Participate in audit planning, inspection readiness, quality documentation reviews, and continuous improvement efforts.
• Mentor junior team members and support onboarding and training activities.

Qualifications:

• Bachelor's degree in Life Sciences, Pharmacy, Nursing, Public Health, Biostatistics, Clinical Research, or a related field.
• Minimum 4 years of experience in clinical research, quality assurance, GCP compliance, or related areas.
• Strong knowledge of ICH-GCP, FDA and EMA regulations, and global clinical trial requirements.
• Experience with data analysis, quality management systems, and Microsoft Office applications.
• Ability to work independently and manage multiple priorities.

Must-Have Skills:

• ICH-GCP
• FDA and EMA regulations
• Clinical trial processes
• Data integrity
• Microsoft Office

Preferred Skills:

• GCP, RCA, Lean Six Sigma, or ASQ certifications
• Risk-Based Quality Management (RBQM) and Risk-Based Monitoring (RBM)
• TrackWise or electronic Quality Management Systems (eQMS)
• Clinical Data Management, Biostatistics, or Clinical Analytics
• Audit support, inspection readiness, CAPA management, root cause analysis, and trend analysis

EOE Statement: Specialist Staffing Group is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or veteran status.

In addition to base pay, employees may be eligible for benefits such as health insurance, health savings accounts, retirement savings plans, life and disability insurance, and paid leave where required by applicable law. Eligibility may vary based on factors such as location and hire date and is subject to change.

To find out more about Real, please visit www.realstaffing.com