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Triangle Park Road, Charlotte, NC, USA
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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
Bachelor's degree
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