Overview
Quality Assurance Specialist Jobs in Durham, NC at ALOIS Solutions
Title: Quality Assurance Specialist
Company: ALOIS Solutions
Location: Durham, NC
Job Details:
Title: Quality Assurance Specialist II
Hours: 30 hours a week
Location: Durham, NC
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 laboratories
- Audit studies, processes, reports, records, and data for accuracy and compliance with applicable regulations.
- 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.
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, 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.
