Senior Quality Assurance Specialist

About the role

Protara Therapeutics is a clinical-stage biotechnology company advancing transformative therapies for cancer and rare diseases. The Senior Quality Specialist will provide GMP-focused quality assurance support, ensuring documentation accuracy, compliance, and inspection readiness while collaborating across teams to strengthen the Quality Management System.

Responsibilities

• Review GMP documentation (SOPs, batch records, protocols, reports, deviations, CAPAs, change controls, training records, etc.) for accuracy, completeness, traceability, and adherence to internal requirements and regulatory expectations
• Assess documentation against current GMP expectations, data integrity principles, and quality system requirements
• Identify gaps that may pose compliance, inspection, or quality risks and provide risk-based feedback to document owners and cross-functional partners
• Review analytical testing documentation, qualification/validation files, laboratory investigations, and certificates of analysis
• Support utilities, facility, equipment, and computer system qualification/validation documentation reviews
• Assist in remediation planning by defining corrective actions, documentation updates, record corrections, process improvements, and follow-up activities
• Track documentation review activities, gap assessments, and remediation deliverables to ensure timely closure and escalation
• Partner with Quality Assurance and 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
• Maintain chain of custody and chain of identity requirements where applicable
• Support internal and external product transfers (technology and material transfers) ensuring compliance with quality agreements, procedures, and regulatory requirements
• Participate in qualification and oversight of CMOs, laboratories, and third-party service providers
• Collaborate with Manufacturing and external partners to resolve quality issues and support delivery timelines

Requirements

• Bachelor’s degree in biology, chemistry, microbiology, biotechnology, pharmaceutical sciences, engineering, or related scientific discipline
• 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
• Experience with change controls, deviations, investigations, CAPAs, and quality systems
• Experience supporting analytical testing and quality control operations
• 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

Skills

• Proficiency in MS Office Suite
• Strong attention to detail and ability to evaluate documentation for accuracy, completeness, consistency, and compliance
• Sound judgment and risk-based decision-making in a regulated environment
• Clear written and verbal communication skills, including explaining 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

Benefits

• Friendly, open, and fun team-oriented culture that values unique and diverse perspectives
• Company-wide dedication to profoundly impacting patients’ lives
• Core values and behaviors shared cross-functionally
• Flexible working hours/schedule
• Generous paid holidays and unlimited PTO
• Competitive compensation and benefits package including incentive bonus, equity compensation, matching 401(k), medical, dental, vision, commuter, and fertility benefits

Pay

Salary range: $80,000–$86,000 based on job-related knowledge, experience, education, and demonstrated skills.