Quality Assurance Compliance Specialist - QE/CAPA Management (Clinical Trials)

About the Role

We are seeking a highly driven Quality Assurance Compliance Specialist with focused expertise in Quality Events (QE) and CAPA (Corrective and Preventive Actions) management within clinical trial or regulated life sciences sectors. The role concentrates on detailed procedural investigations, root cause analysis, and managing CAPA processes through TrackWise Digital or comparable quality management platforms. Candidates must be located within EST, CST, or MST time zones to align with flexible 8-hour work schedules.

Key Responsibilities

• Oversee and investigate Quality Events, deviations, and compliance issues related to clinical trial operations.
• Conduct comprehensive root cause analyses and formulate effective CAPA strategies.
• Ensure comprehensive and timely documentation, tracking, and resolution of CAPAs using TrackWise Digital or similar QMS tools.
• Support compliance activities adhering to FDA, GxP, SOP, and relevant regulatory standards.
• Identify procedural shortcomings and suggest preventive measures to avoid recurrence.
• Work collaboratively across departments to address quality and compliance challenges.
• Maintain precise and audit-ready quality documentation.
• Participate actively in internal audits, inspections, and quality reviews.
• Properly escalate significant compliance risks when necessary.

Required Qualifications

• 3 to 7 years of experience in QA Compliance within clinical trials, pharmaceutical, biotechnology, or CRO environments.
• Practical knowledge handling Quality Events and CAPAs.
• Solid understanding of Root Cause Analysis, GxP, FDA regulations, SOP compliance, and clinical quality systems.
• Experience with TrackWise Digital or equivalent Quality Management Systems.
• Strong English communication skills, verbal and written.
• Proven ability to perform calmly and effectively in high-pressure situations.
• Capable problem-solving and investigative approach.
• Experience working with challenging stakeholders and cross-functional teams.

Preferred Qualifications

• Background supporting regulatory inspections or audits.
• Familiarity with clinical trial operations and quality workflows.
• Experience in highly regulated healthcare or life sciences environments.

Soft Skills

• Inquisitive and investigative mindset.
• Exceptional attention to detail.
• Strong organizational capabilities.
• Motivation to explore root causes and underlying issues.
• Effective collaboration and professionalism under pressure.

Industry Experience Recommended

• Clinical Trials
• Pharmaceuticals
• Biotechnology
• Clinical Research Organizations (CRO)
• FDA/GxP-Regulated Industries

Work Schedule and Compensation

• Hourly rate: $30 on W2 basis.
• Flexible 8-hour daily schedule: 8:00 AM–5:00 PM or 9:00 AM–6:00 PM, aligned to the candidate’s local time zone within the specified US time zones.

Additional Information

This position is fully remote but restricted to candidates residing in EST, CST, or MST time zones. Candidates must be legally authorized to work in the United States. The role includes participation in 1 to 2 interview rounds. The employer is an equal opportunity organization with a diverse and inclusive workplace culture. Employment is at-will, and all applicant data is handled per privacy regulations including CCPA.

Benefits Provided

• Comprehensive medical, dental, and vision insurance coverage.
• Paid holidays and paid time off eligibility.
• Access to a 401(k) retirement savings plan.

About the Company

BCforward is a Black-owned firm established in 1998 focused on workforce management and professional services. It supports clients globally with a team of over 6,000 consultants across locations including Indianapolis, IN, and Hyderabad, India. The company emphasizes a culture built on people-first values such as optimism, diversity, excellence, and accountability, ensuring a market leading position and strong employee commitment.