Senior Quality Associate

Scorpion Therapeutics; Morrisville (NC); On-site; USD 65,000 - 90,000; Full time

Job summary

Scorpion Therapeutics is seeking a Senior Quality Associate to support GMP quality systems within a biopharma environment focused on pulmonary therapies. You will help manage deviations, CAPA, and document control, ensuring compliance and readiness for inspections.

The role collaborates with manufacturing and QC teams to develop SOPs, monitor quality trends, and drive continuous improvement. A Bachelor's in Life Sciences and 2+ years of QA experience are required with knowledge of GMP and

Qualifications

• Bachelor's degree in Life Sciences or related field.
• 2+ years QA experience in regulated industry.
• Knowledge of quality systems, GMP and regulatory inspections.
• Experience with electronic platforms like Veeva or Kneat preferred.
• Strong organizational, communication, and detail orientation skills.

Responsibilities

• Manage deviation, change control, CAPA and document systems.
• Support manufacturing and QC operations.
• Develop SOPs and assist in management reviews.
• Monitor quality trends and compliance.
• Promote inspection readiness and continuous improvement.

Skills

Organizational skills

Communication

Attention to detail

Education

Bachelor's degree in Life Sciences or related field

Tools

Veeva

Kneat

Job description

Senior Quality Associate

Role: Senior Quality Associate supporting GMP quality systems within a biopharma focused on pulmonary hypertension therapies, combining proprietary PRINT Technology with established medications.

Responsibilities

Responsibilities: manage deviation, change control, CAPA, and document systems; support manufacturing and QC operations; develop SOPs; assist in management reviews; monitor quality trends and compliance; promote inspection readiness and continuous improvement.

Requirements

Requirements: Bachelor's in Life Sciences or related field; 2+ years QA experience in regulated industry; knowledge of quality systems, GMP, and regulatory inspections; experience with electronic platforms like Veeva or Kneat preferred; strong organizational, communication, and detail orientation skills.

High Value

HighValue: GMP compliance, deviation and CAPA management, regulated industry experience, electronic document platforms, pulmonary hypertension therapy focus, inspection readiness.

Work Setup

WorkSetup: not specified; requires compliance and quality assurance expertise.