Senior QA Specialist, GMP & Documentation Lead

Initial Therapeutics, Inc.; North Carolina; On-site; USD 80,000 - 86,000; Full time

Benefits offered by this job

Flexible working hours

Unlimited PTO

Equity compensation

Job summary

Protara Therapeutics seeks a Senior Quality Specialist to provide QA support for GMP activities, reviewing controlled documents and records for accuracy, completeness, and compliance. You will identify gaps, advise cross-functional partners, and help strengthen the Quality Management System and inspection readiness.

This role requires on-site work five days per week and involves collaboration with QA, Manufacturing, and Regulatory teams to ensure product quality and patient safety across

Qualifications

• 5+ years of experience in Quality Assurance or GMP-regulated environments.
• Experience supporting clinical manufacturing operations and batch release.
• Strong experience with CAPAs, deviations, investigations, and change controls.
• Experience working in a cGMP-regulated environment.

Responsibilities

• Review GMP documentation (SOPs, batch records, protocols, reports, deviations) for accuracy and traceability.
• Identify gaps and provide risk-based input to stakeholders.
• Support inspection readiness and regulatory/document control activities.
• Assist with qualification/validation documentation and site transfers as needed.
• Promote a culture of quality and continuous improvement across teams.

Skills

Attention to detail

Risk-based judgments

Written & verbal communication

Education

Bachelors in biology, chemistry, microbiology, biotech, pharma science, eng

Tools

MS Office Suite

Job description

Protara Therapeutics seeks a Senior Quality Specialist to provide QA support for GMP activities, reviewing controlled documents and records for accuracy, completeness, and compliance. You will identify gaps, advise cross-functional partners, and help strengthen the Quality Management System and inspection readiness.

This role requires on-site work five days per week and involves collaboration with QA, Manufacturing, and Regulatory teams to ensure product quality and patient safety across