Description

Responsibilities & Accountabilities

· Assess and assure study, project, and process compliance with protocols, controlled documents, and applicable regulations and guidelines through audits of client

· Audit 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.

· Based on knowledge of regulations, guidelines and relevant SOPs, support staff by acting as a technical resource for compliance-related issues.

· Other duties, as assigned by Quality Assurance Management.

About you

Education/ Qualifications:

· 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.

Experience, skills, and characteristics:

Laboratory and/or Quality Assurance experience in a laboratory setting.

· Audit experience, required

· Robust knowledge of immunogenicity (NAb and TAb) and ddPCR assays is 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 multitask among multiple projects and tasks simultaneously.

· Excellent interpersonal, verbal, and written communication skills.

· Proficiency in MS Word, Excel, PowerPoint, and other applications

Key Skills

Education

Bachelor's degree