Sr. Quality Assurance Specialist

Senior Specialist, Quality Assurance The Senior Specialist, Quality Assurance provides Quality Assurance (QA) oversight of AskBio’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. Job Responsibilities Maintain and manage a risk‑based model for qualification and quality oversight of GCLP, GCP, GLP vendors in compliance with AskBio 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%). Minimum 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 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. Preferred Education, Experience, and Skills 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). Equal Employment Opportunity AskBio Inc. (AskBio) 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 View phone number on click.appcast.io or sending an email to View email address on click.appcast.io. Agency Statement Agencies: Please do not contact any employee at AskBio about this requisition. Any resume submitted by a recruitment agency to any employee at AskBio, through any medium, will be deemed the sole property of AskBio unless the agency was engaged by AskBio Talent Acquisition team to recruit for that position. All agencies must have a prior executed service agreement with AskBio prior to any search engagement. If a candidate who was submitted outside of the AskBio agency process is hired by AskBio, no fee or payment of any kind will be paid to the agency. #J-18808-Ljbffr AskBio