Senior QA Specialist — GMP Documentation & Compliance

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

Benefits offered by this job

Incentive bonus

Equity compensation

Matching 401(k)

Medical

Dental

Vision

Commuter

Fertility benefits

Job summary

Protara Therapeutics, Inc. seeks a Senior Quality Specialist to provide QA support for GMP activities, review controlled documents, and help strengthen the Quality Management System. On-site 5 days/week, you will work with cross-functional teams to close gaps and improve data integrity.

Ideal candidates have 5+ years in GMP QA, experience with batch release, CAPAs, and CMOs, plus a strong attention to detail and clear communication.

Qualifications

• Bachelor’s degree in a scientific discipline.
• 5+ years of experience in Quality Assurance, Quality Systems or GMP-regulated environments.
• Experience supporting clinical manufacturing operations and batch release.
• Experience reviewing controlled documents, investigations, CAPAs and change controls.

Responsibilities

• Review GMP documentation (SOPs, batch records, deviations) for accuracy and traceability.
• Assess documentation against GMP expectations and quality system requirements.
• Identify gaps and provide risk-based feedback for remediation.
• Assist with inspection readiness and internal audits.
• Coordinate with CMOs and cross-functional teams to ensure compliance.
• Support transfer activities and documentation packages for regulatory review.

Skills

Attention to detail

Written communication

Analytical thinking

Problem solving

Risk-based decision making

Education

Bachelor’s degree in biology, chemistry, microbiology, biotechnology, pharmaceutical sciences, engineering

Tools

MS Office Suite

Job description

Protara Therapeutics, Inc. seeks a Senior Quality Specialist to provide QA support for GMP activities, review controlled documents, and help strengthen the Quality Management System. On-site 5 days/week, you will work with cross-functional teams to close gaps and improve data integrity.

Ideal candidates have 5+ years in GMP QA, experience with batch release, CAPAs, and CMOs, plus a strong attention to detail and clear communication.