Senior Quality Assurance Specialist-Temp

Senior Quality Assurance Specialist-Temp

North Carolina

Protara Therapeutics is a clinical-stage biotechnology company committed to advancing transformative therapies for people with cancer and rare diseases. Protara’s portfolio includes its lead candidate, TARA-002, an investigational cell-based therapy in development for the treatment of non-muscle invasive bladder cancer (NMIBC) and lymphatic malformations (LMs). The Company is evaluating TARA-002 in an ongoing Phase 2 trial in NMIBC patients with carcinoma in situ (CIS) who are unresponsive or naïve to treatment with Bacillus Calmette-Guérin (BCG), as well as a Phase 2 trial in pediatric patients with LMs.

Additionally, Protara is developing IV Choline Chloride, an investigational phospholipid substrate replacement for patients on parenteral support who are otherwise unable to meet their choline needs via oral or enteral routes.

The Senior Quality Specialist-Temp will provide quality assurance support for GMP activities by reviewing controlled documents and records for accuracy, completeness, consistency, and compliance with applicable procedures, quality standards, and regulatory expectations. This role will identify documentation and process gaps, provide practical compliance input to cross-functional stakeholders, and support activities that strengthen inspection readiness, data integrity, and the overall effectiveness of the Quality Management System.

The person must be able to work on site 5 days per week.

40 hours a week for three weeks and then continue at 25 hours a week for 4 months.

• 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

• Collaborate with Manufacturing and external partners to resolve quality issues and support delivery timelines
• Foster a quality culture focused on compliance, operational excellence, and patient safety

• Bachelor’s degree in biology, Chemistry, Microbiology, Biotechnology,…