Senior QA Specialist - GMP Compliance (Onsite)

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

Benefits offered by this job

Team-oriented culture

Impactful work

Strong culture

Flexible schedule

Paid holidays & unlimited PTO

Job summary

Protara Therapeutics, a clinical-stage biotechnology company, seeks a Senior Quality Specialist to provide QA support for GMP activities. The role focuses on reviewing controlled documents and records, identifying gaps, and strengthening the Quality Management System to support inspection readiness and data integrity.

The position requires on-site work five days a week and collaboration with cross-functional teams to ensure compliance and continuous improvement in documentation practices.

Qualifications

• 5+ years of experience in Quality Assurance, Quality Systems, Document Control, Manufacturing Quality or a related GMP-regulated environment.
• Experience supporting clinical manufacturing operations and batch release activities.
• Strong experience with change controls, deviations, investigations, CAPAs and quality systems.
• Experience supporting analytical testing and quality control operations.
• Experience working in a cGMP-regulated environment.

Responsibilities

• Review GMP documentation, including SOPs, batch records, protocols, reports, forms, deviations, CAPAs, change controls, training records, and other quality records, for accuracy, completeness, traceability, and adherence to internal requirements
• Assess documentation against current GMP expectations, approved procedures, data integrity principles, and established quality system requirements
• Identify gaps that may create compliance, inspection, or quality risks
• Provide clear, risk-based feedback to document owners, subject matter experts, and cross-functional partners to support timely correction and effective remediation
• Review analytical testing documentation, qualification/validation documents, laboratory investigations, and certificates of analysis
• Review utilities, facility, equipment and computer qualification/validation documentation
• Support remediation planning by helping define corrective actions, documentation updates, record corrections, process improvements, and follow-up activities
• Track assigned documentation review activities, gap assessments, and remediation deliverables to ensure timely closure and appropriate escalation of issues
• Partner with Protara Quality Assurance and contract manufacturing organizations (CMOs) to ensure documentation reflects actual practices and remains inspection ready
• Support continuous improvement of documentation review processes, templates, workflows, and quality system practices
• Assist with inspection readiness activities, internal audits and preparation of documentation packages for regulatory or internal review
• Promote a strong quality culture by reinforcing good documentation practices, compliance awareness, and accountability across functional teams
• Ensure chain of custody and chain of identity requirements are maintained, where applicable
• Support internal and external product transfers, including technology transfers and material transfers between manufacturing sites and contract organizations
• Ensure transfer activities comply with quality agreements, procedures, and regulatory requirements
• Participate in qualification and oversight of CMOs, laboratories and third-party service providers as needed

Skills

5+ years QA

Change controls

Deviations

Investigations

CAPAs

Quality systems

cGMP experience

Education

Bachelor’s degree in a scientific field

Tools

MS Office

Job description

Protara Therapeutics, a clinical-stage biotechnology company, seeks a Senior Quality Specialist to provide QA support for GMP activities. The role focuses on reviewing controlled documents and records, identifying gaps, and strengthening the Quality Management System to support inspection readiness and data integrity.

The position requires on-site work five days a week and collaboration with cross-functional teams to ensure compliance and continuous improvement in documentation practices.