Bioanalytical Quality Associate

MESO SCALE DIAGNOSTICS, LLC.•Gaithersburg, MD

12d•$78,100 - $116,200•Hybrid

About The Position

The Bioanalytical Quality Associate is responsible for verifying adherence to laboratory policies and procedures which influence the quality of the laboratory’s services. Additionally, this position acts as a technical reviewer of all Bioanalytical Study Reports and Study Files prior to customer delivery, plans and executes internal audits of the laboratory operations, supports resolution of audit findings, and provides recommendations to management for continuous quality improvements.

Requirements

Bachelor’s degree in health or science related field.
Five years’ minimum experience in a Quality role, preferably in a GLP laboratory/cGMP environment
Strong scientific fundamentals and analytical background.
Demonstrate understanding and verification of scientific text and data.
Awareness of GLP, FDA Guidance for Industry, and CLIA regulations.
Ability to initiate projects and to work independently, as well as a part of a team including technical and clinical subject matter experts.
Strong organizational and project management skills with the ability to organize multiple tasks and set priorities under deadlines with minimal supervision.
Proficiency in MS Office suite; familiarity with electronic file management using SharePoint (end user minimum) and MS Excel is necessary.

Nice To Haves

Professional Quality Certification (e.g., ASQ, ASCP) is a plus.
Experience with protein-based immunoassays, running antibody-based assays, developing reagents and product development is desirable.
Training and experience in a Biosafety Level 2 (BSL-2) laboratory is preferred.

Responsibilities

Perform technical reviews of sample testing Study Reports and Study Files.
QC review of Report contents such as project details, analytical data, result specifications, and conclusions.
QC review of adherence to data transfer specifications (DTS), as applicable.
Examine Study files for completeness, report findings and recommendations to the Bioanalytical Principal Investigator (BPI) and laboratory management.
Collaborate with BPI to oversee resolution of all findings and facilitate required documentation and closure (deviation, variance, CAPA, etc.).
Provide management with monthly summary of technical reviews, audit findings, and deviations.
Manage archiving activities for study records and data, in accordance with established standard operating procedures.
Plan and oversee internal audits of the laboratory processes, Good Laboratory Practices/Good Clinical Laboratory Practices (GLP/GCLP) studies, training files, competency assessments, and archives.
Hold audit de-briefings to cover gaps and audit findings
Manage the resolution and closure of gaps and audit findings
Manage process for continuous improvement initiatives
Act as subject matter expert (SME) for laboratory documentation change orders and training initiatives
Provide recommendations for LIMS workflow improvements, based on audit findings
Ensure laboratory facility and equipment are suitable and in compliance with required operating conditions
Oversee functional responsibilities of lab designees (maintenance activities and documentation).
Supervise scheduled calibrations, equipment maintenance and qualifications (IQ/OQ/PQ).
Administer the OCEASoft monitoring system for Bioanalytical assets.
Communicate with management regarding inadequacies and resolution plans for equipment failures or facility issues
Utilize self-reliance in understanding and adhering to laboratory safety precautions and proper use of personal protective equipment.