Jobs at Protara Therapeutics

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.

• 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

Cross-Functional Collaboration

• 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

 Education/ Qualifications:

•  Bachelor’s degree in biology, Chemistry, Microbiology, Biotechnology, Pharmaceutical Sciences, Engineering, or related scientific discipline

Experience:

• 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
• Bachelor’s degree in a scientific, technical, engineering, quality, or related discipline preferred; equivalent experience may be considered
• Working knowledge of current GMP requirements, good documentation practices, data integrity expectations, and quality system processes
• Experience reviewing controlled documents, GMP records, investigations, CAPAs, change controls, protocols, reports, or similar quality documentation
• Demonstrated ability to identify gaps, assess risk, recommend practical solutions, and support remediation through closure

Computer Skills:

• Must be proficient in MS Office Suite

Other Skills and Abilities:

• Strong attention to detail and ability to evaluate documentation for accuracy, completeness, consistency, and compliance
• Sound judgment and risk-based decision-making skills in a regulated environment
• Clear written and verbal communication skills, including the ability to explain documentation issues and remediation expectations to cross-functional stakeholders
• Ability to work independently, manage multiple priorities, and meet deadlines in a fast-paced environment
• Collaborative mindset with the ability to build effective working relationships across Quality, Operations, Technical, and Regulatory functions
• Strong analytical, problem-solving, and follow-through skills
• Commitment to quality, compliance, patient safety, and continuous improvement