Pay 35-40/h depending on experience About the role This position is responsible for providing QA oversight and auditing of activities related to clinical and preclinical studies. Examples of activities within the scope of oversight and auditing include but are not limited to: preclinical animal studies, sample analysis from clinical (GCLP guidelines) and preclinical studies (GLP regulations), qualification and/or validation of methods, laboratory processes, etc. This role will assure corporate compliance with applicable

GCP, GLP, GCLP

national, international, and state regulations and guidelines. This position will report to the Quality Assurance Manager (GCP/GLP). Responsibilities & Accountabilities

• Assess and assure study, project, and process compliance with protocols, controlled documents, and applicable regulations and guidelines through audits of company laboratories
• 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 5+ 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, 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
• Excellent interpersonal, verbal, and written communication skills.
• Proficiency in MS Word, Excel, PowerPoint, and other applications