Quality Assurance Specialist II

• Assess and assure study, project, and process compliance with protocols, controlled documents, and applicable regulations and guidelines through audits of AskBio laboratories
• Audit systems, studies, processes, reports, records, and data for accuracy and compliance with applicable regulations. Follow up on any audit findings.
• Perform in-process inspections of nonclinical study phases and assay methods.
• Review study events, deviations, investigations, and change control documentation to assess acceptability of content and documentation.
• Detect Quality Issues and assist Quality Assurance Management with corrective and preventative action process.
• Participate in improvement initiatives intended to improve quality, study compliance, processes, study data, and reports.
• Based on knowledge of regulations, guidelines and relevant SOPs, support staff by acting as a technical resource for compliance related issues.
• Contribute to the development, implementation, and maintenance of SOPs.
• Other duties, as assigned by Quality Assurance Management.

• Quality Assurance Specialist - Bachelor's degree, in a health care or relevant scientific field and 3+ years of relevant industry experience.
• Knowledge: Knowledge of industry best practices and regulatory requirements (Good Clinical Laboratory Practice, Good Laboratory Practice, a solid understanding of 21 CFR Part 11, and laboratory standards relevant to clinical and preclinical laboratory research).
• Knowledge of GCPs a plus but not required.

• Audit experience, required
• Robust knowledge of immunogenicity and ddPCR assay, required
• Strong collaborative skills. Must be able to effectively collaborate cross-functionally with peers, scientific and technical staff; and be comfortable working in a matrixed team.
• Ability to identify and/or resolve quality issues/discrepancies with others in a proactive, diplomatic, flexible, and constructive manner.
• Ability to prioritize, organize, work independently, and multi-task among multiple projects and tasks simultaneously.
• Excellent interpersonal, verbal, and written communication skills.
• Proficiency in MS Word, Excel, PowerPoint, and other applications.

Why TalentBurst?
At TalentBurst, we deliver more than talent, we deliver outcomes. We partner with you to move quickly and connect you to opportunities aligned with your skills and long term growth.

Backed by precision, transparency, and results, we connect top talent with leading organizations through trusted partnerships.

We offer competitive compensation and comprehensive benefits, including medical, dental, vision, and retirement options.

TalentBurst is an equal opportunity employer committed to an inclusive and diverse workforce.