Quality Assurance Specialist III

Job Titles: Quality Assurance Specialist III
Location:   Research Triangle Park, NC 27709
Duration:  6 months
Payrate:    $30/hr - $40/hr on W2
 
Job Description:

• 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).

• Assess and assure study, project, and process compliance with protocols, controlled documents, and applicable regulations and guidelines through audits of AskBio 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.

• Bachelor's degree, in a health care or relevant scientific field and 5+ years of relevant industry experience.
• 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.

• 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