Sr. Quality Assurance Specialist

AskBio • Durham, NC

22h • Onsite

About The Position

This role is a secondment opportunity at AskBio, a company focused on advancing gene therapy. The Senior Specialist, Quality Assurance will provide Quality Assurance (QA) oversight of AskBio’s Vendor Qualification Program for GCLP, GLP, GCP, and GMP vendors. The individual will perform vendor assessments and audits, ensuring compliance with relevant guidelines and regulations. This position will collaborate closely with GCP/GLP/GCLP QA and Subject Matter Experts (SMEs). The role is office-based in RTP, NC and reports to the Senior Director, QA – Product Quality.

Requirements

• Bachelor’s degree in science, health care, business, or other relevant field and 5+ years of relevant industry experience.
• Knowledge of industry best practices and regulatory requirements, including, Good Clinical Laboratory Practices (GCLP), Good Laboratory Practices (GLP), Good Clinical Practices (GCP).
• Experience in vendor qualification or vendor management.
• Strong collaborative skills; ability to work cross-functionally in a matrixed environment.
• Ability to proactively and diplomatically identify and resolve quality issues/discrepancies.
• Ability to prioritize, organize, work independently, and manage multiple projects/tasks simultaneously.
• Analytical mindset with strong attention to detail.
• Excellent interpersonal, verbal, and written communication skills.
• Proficiency in MS Word, Excel, PowerPoint, and other applications.

Nice To Haves

• Laboratory, clinical research, and/or Quality Assurance (or related) experience.
• Audit experience, including ASQ certification for auditing (CQA) or similar.
• Knowledge of Good Manufacturing Practices (GMP).

Responsibilities

• Maintain and manage a risk-based model for qualification and quality oversight of GCLP, GCP, GLP vendors (and GMP vendors, as needed) in compliance with AskBio SOPs.
• Assure the conduct of regular vendor assessments or audits of GCLP, GCP, GLP (and GMP vendors, as needed) to evaluate regulatory compliance, performance, and improvement opportunities (via questionnaire and/or audit), involving GCP/GLP/GCLP QA and SMEs, as appropriate.
• Serve as primary interface with GCP/GLP/GCLP QA and related functional area staff on topics relevant to vendor qualification.
• Identify, track status, and schedule audits and assessments of GCLP, GCP, GLP (and GMP vendors, as needed) vendors.
• Advance the Vendor Qualification program by identifying opportunities and implementing risk-appropriate enhancements to program infrastructure.
• Support functional area staff to resolve vendor observations and quality issues, including risk/impact assessment and CAPA development, execution, and effectiveness checks.
• Maintain and evolve mechanisms that ensure awareness and application of Vendor Qualification QMS requirements.
• Contribute to the development, implementation, and maintenance of SOPs, Policies, and Quality Agreements.
• Support coordination and management of regulatory agency inspections and parent company audits, as appropriate.
• Perform other duties as assigned by Quality Assurance Management.

What This Job Offers

• Job Type: Full-time
• Career Level: Senior