Senior GMP QA Specialist: Documentation & Compliance

BioSpace; North Carolina; On-site; USD 80,000 - 86,000; Full time

Benefits offered by this job

Incentive bonus

Equity compensation

Medical, dental, vision

401(k) matching

Fertility benefits

Job summary

Protara Therapeutics is seeking a Senior Quality Specialist to provide QA support for GMP activities, review controlled documents, and strengthen the Quality Management System. The role emphasizes inspection readiness, data integrity, and cross-functional collaboration across QA, Manufacturing, and Regulatory teams.

The position requires a Bachelor’s degree in a scientific field and 5+ years of GMP experience, with a onsite work requirement.

Qualifications

• Bachelor’s degree in a scientific discipline relevant to QA
• 5+ years of experience in Quality Assurance, Quality Systems, Document Control, or GMP-regulated environments
• Experience supporting clinical manufacturing operations and batch release
• Strong experience with change controls, deviations, investigations, CAPAs, and quality systems
• Experience reviewing controlled documents, GMP records, investigations, and quality documentation
• Working knowledge of GMP requirements, data integrity, and quality system processes

Responsibilities

• Review GMP documentation such as SOPs, batch records, protocols, reports, and deviations for accuracy and completeness
• Assess documentation against GMP expectations and established quality system requirements
• Identify gaps that may create compliance or quality risks
• Provide risk-based feedback to document owners and cross-functional partners
• Support remediation planning and closure of corrective actions
• Coordinate with CMOs and internal QA to ensure documentation reflects actual practices
• Assist with inspection readiness activities and internal audits
• Promote a strong quality culture across functions
• Ensure chain of custody/identity where applicable
• Support product transfers and technology transfers between sites

Skills

Attention to detail

Communication

Time management

Problem solving

Education

Bachelor’s degree in biology, chemistry, microbiology, biotech, pharma sciences, engineering, or related

Tools

MS Office Suite

Job description

Protara Therapeutics is seeking a Senior Quality Specialist to provide QA support for GMP activities, review controlled documents, and strengthen the Quality Management System. The role emphasizes inspection readiness, data integrity, and cross-functional collaboration across QA, Manufacturing, and Regulatory teams.

The position requires a Bachelor’s degree in a scientific field and 5+ years of GMP experience, with a onsite work requirement.