Senior Quality Assurance Specialist

Job description

**Company Overview:** 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. Protara was named one of the **Best Places to Work** by BioSpace, a leading industry news and job source. This honor demonstrates the company’s desirability in the recruitment marketplace, looking at various merits with an emphasis on culture, career growth and development opportunities, leadership and innovation. Attracting and retaining top talent is integral to building a successful company in biotech, and we are committed to ensuring Protara provides our employees with an exceptional experience throughout their careers, even as we continue to grow. **Job Overview:** The Senior Quality Specialist 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. **\*This person must be able to work on site 5 days per week.** *\****Essential Duties and Responsibilities** include the following. Other duties may be assigned. **Key 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 **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 **Certificates, Licenses, Registrations:**none required **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 **Why You’ll Love Working at Protara** - Friendly, open, and fun team-oriented culture that values unique & diverse perspectives. - Company-wide dedication to profoundly impacting patients’ lives. - Amazing culture whereby our core values and behaviors are shared cross-functionally. - Flexible working hours/schedule. - Generous Paid Holidays and Unlimited PTO. **Physical Demands:** *The physical demands here are representative of those that must be met by an employee to successfully perform the essential functions of this job.* **Work Environment:** *The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job.* - No specific work demands. *To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed above are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.* **\***Salary Requirements are between $80,000-$86,000 based on job-related knowledge, experience, education, and skills demonstrated. We offer a competitive Compensation & Benefits package including incentive bonus, equity compensation, matching 401(k), medical, dental, vision, commuter, and fertility benefits. *Protara is committed to being a diverse and inclusive workplace. Protara is an Equal Opportunity Employer and is committed in policy and in practice to recruit, hire, train, and promote in all job qualifications without regard to race, color, creed, religion, national or ethnic origin, citizenship status, age, sex or gender, gender identity or expression (including transgender status), sexual orientation, marital status, military service and veteran status, disability, genetic information or any other characteristic protected by applicable federal, state or local laws*.