Search Jobs
Quality Assurance Specialist
Research Triangle Park, NC 00277
Job Description
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.
- Quality Assurance Specialist - Bachelor’s degree, in 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 is 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 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
Meet Your Recruiter
Share This Job:
Related Jobs:
Login to save this search and get notified of similar positions.About Research Triangle Park, NC
Staffing Leader of the Year Anju Abel
CEO, LanceSoft
LanceSoft is proud to announce that its Chief Executive Officer, Anju Abel, has been honored with the prestigious "Staffing Leader of the Year" award at the 2025 TIARA Staffing Awards US. The award recognizes her visionary leadership and significant contributions to improving staffing processes, employee engagement, and workforce outcomes.
Anju Abel's leadership has been instrumental in transforming LanceSoft's global staffing operations. Her focus on innovation, employee satisfaction, and client-centric delivery has led to higher retention rates, a motivated workforce, and enhanced operational efficiency.
"This award is a testament to the incredible team at LanceSoft and our unwavering commitment to redefining staffing solutions," said Anju Abel. "I'm honored to receive this recognition and proud of the impact we continue to make in the lives of our clients and talent worldwide."
The judging panel highlighted Anju's ability to consistently deliver outstanding client success stories, exceed expectations, and foster professional development within her team. Her active community involvement and dedication to advancing the staffing industry were also key factors in her selection.
TIARA Awards are known for celebrating excellence, innovation, and achievement in the talent acquisition sector, and this accolade places Anju among the top leaders reshaping the future of workforce solutions.