Main purpose of the position The Quality Assistant will provide quality oversight for immunology laboratory operations, supporting the development, implementation, and monitoring of the laboratory’s Quality Management System (QMS).
The role ensures GCLP and regulatory compliance, supports internal and external audits, and fosters continuous quality improvement. Key Responsibilities
1. Quality Systems Oversight (50%) a) Monitor GCLP compliance and coordinate internal audits, document control, training, and deviation management.
b) Support assay validation, performance verification, and SOP implementation.
c) Drive continuous quality improvement initiatives and maintain QA documentation.
d) Ensure safe handling of clinical specimens and adherence to IRB protocols.
2. Laboratory Practice Support (20%) a) Assist in monitoring assay quality (ELISA, ELISpot, Neutralization), specimen processing, and batch record review.
b) Support staff in maintaining validation standards and regulatory documentation.
3. Management & Leadership (15%) a) Support laboratory leadership in staff training, operations oversight, and resource planning. b) Promote a culture of safety, ethics, and professionalism.
. Communication & Reporting (10%) a) Prepare QA reports, contribute to internal communications, and support stakeholder engagement. b) Provide technical input into procurement and compliance-related decisions.
5. Ethics & Compliance (5%) a) Ensure alignment with UVRI-REC and UNCST guidelines, including protocol adherence and ethical conduct.
Minimum Qualifications and Experience a) Bachelor’s degree in Biological or Laboratory Science, Immunology, Quality management, or related field.
b) At least one year’s laboratory experience in a GCLP-compliant environment.
c) Familiarity with laboratory accreditation, QA audits, and regulatory compliance. d) Strong interpersonal, communication, and data analysis skills.
e) Must achieve GCLP proficiency within 3 months of hiring. Desirable: 1. Experience in laboratory safety, quality improvement, or project management. 2. Proficiency with LIMS and statistical tools.
