Client: Biotechnology Research
Title: Quality Assurance Specialist II
Duration: 06+ months Contract (Possibility of extension)
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 and preclinical studies, qualification and/or validation of methods, equipment/software validation, laboratory processes, etc. This role will assure corporate compliance with applicable GCP, GLP, GCLP national, international, and state regulations and guidelines.
Responsibilities & Accountabilities:
- Assess and assure study, project, and process compliance with protocols, controlled documents, and applicable regulations and guidelines through audits of laboratories
- Review study events, deviations, investigations, and change control documentation to assess acceptability of content and documentation.
- Detect Quality Issues and assist Quality Assurance Management with corrective and preventative action process.
- Participate in improvement initiatives intended to improve quality, study compliance, processes, study data, and reports.
- Based on knowledge of regulations, guidelines and relevant SOPs, support staff by acting as a technical resource for compliance related issues.
- Contribute to the development, implementation, and maintenance of SOPs.
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 and ddPCR assay, required
