职位描述

About the Role

BCforward is seeking a motivated Quality Analyst to join remotely within the United States (preferred EST, MST, or CST time zones) on a 6-month contractual basis with the possibility of extension or conversion. This position focuses on ensuring quality and compliance in clinical trial processes through managing quality events, conducting root cause analyses, and developing corrective and preventive action plans.

Key Duties

Oversee and investigate Quality Events related to clinical trials.
Perform thorough root cause analyses and design CAPA plans.
Maintain adherence to regulatory requirements and internal protocols.
Primarily address procedural CAPAs with some technical involvement as needed.
Keep detailed documentation and prepare reports for audits.
Collaborate effectively with multiple teams in a dynamic, fast-paced setting.

Qualifications

Between 3 to 7 years of professional experience in quality assurance focused on clinical trials.
Demonstrated expertise in managing Quality Events and CAPA processes.
Knowledgeable about relevant regulatory compliance including FDA standards.
Proficient in English communication, both written and verbal.

Preferred Attributes

Strong curiosity and excellent problem-solving skills.
Ability to perform well under pressure and in demanding environments.
Comfort in engaging with challenging stakeholders.
Analytical mindset with emphasis on identifying root causes.

Work Hours

Expected work schedule is a flexible 8-hour day, generally between 8 AM to 5 PM or 9 AM to 6 PM depending on the candidate's time zone.

Quality Analyst