Sr. Quality Assurance Specialist

Senior Specialist, Quality Assurance

The Senior Specialist, Quality Assurance provides Quality Assurance (QA) oversight of Ask Bio’s Vendor Qualification Program for GCLP, GLP, GCP and GMP vendors. The role performs vendor assessments and audits, ensures compliance with guidelines and regulations, and works closely with QA and subject‑matter experts.

• Maintain and manage a risk‑based model for qualification and quality oversight of GCLP, GCP, GLP vendors in compliance with Ask Bio SOPs.
• Assure the conduct of regular vendor assessments or audits of GCLP, GCP, GLP and GMP vendors to evaluate regulatory compliance and improvement opportunities.
• Serve as primary interface with QA and functional area staff on vendor qualification topics.
• Identify, track status, and schedule audits and assessments of vendors.
• Advance the Vendor Qualification program by implementing risk‑appropriate enhancements to program infrastructure.
• Support staff to resolve vendor observations and quality issues, including risk/impact assessment and CAPA development and effectiveness checks.
• Maintain 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.
• Travel may be required to perform audits (approximately 20%).

• 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 GCLP, GLP, and GCP.
• Strong collaborative skills and ability to work cross‑functionally in a matrixed environment.
• Ability to proactively and diplomatically identify and resolve quality issues or discrepancies.
• Ability to prioritize, organize, work independently, and manage multiple projects or 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.

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

Ask Bio Inc. (Ask Bio) is an Equal Opportunity Employer and does not discriminate against any employee or applicant for employment because of race, color, religion, gender, sexual orientation, gender identity, national origin, age, disability, veteran status, or any other protected status prohibited under Federal, State or local laws. All employment decisions are based on valid job‑related requirements. If you are a qualified individual with a disability or a disabled veteran and are unable or limited in your ability to use or access our website, you may request a reasonable accommodation to express interest in a specific opening by calling us at  or sending an email to

Agencies:
Please do not contact any employee at Ask Bio about this requisition. Any resume submitted by a recruitment agency to any employee at Ask Bio, through any medium, will be deemed the sole property of Ask Bio unless the agency was engaged by Ask Bio Talent Acquisition team to recruit for that position. All agencies must have a prior executed service agreement with Ask Bio prior to any search engagement.

If a candidate who was submitted outside of the Ask Bio agency process is hired by Ask Bio, no fee or payment of any kind will be paid to the agency.