Senior Quality Assurance Specialist-Temp

About the role

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.

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
• 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
• Support 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

Qualifications

• 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
• Strong experience with change controls, deviations, investigations, CAPAs, and quality systems
• Experience supporting clinical manufacturing operations and batch release activities
• Experience working in a cGMP-regulated environment
• Preferred: Bachelor’s degree in a scientific, technical, engineering, quality, or related discipline
• Working knowledge of current GMP requirements, good documentation practices, data integrity expectations, and quality system processes
• Demonstrated ability to identify gaps, assess risk, recommend practical solutions, and support remediation through closure
• 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