Laboratory Quality Specialist

ASRT, Inc.•Atlanta, GA

6d•Onsite

About The Position

ASRT, Inc. is seeking a full-time Laboratory Quality Specialist to support the Bacterial Meningitis Laboratory (BML), Quality Management team and M&O team within the Meningitis and Vaccine Preventable Diseases (MVPDB) at the National Center for Immunization and Respiratory Diseases (NCIRD) at the CDC in Atlanta, GA. The role involves providing scientific and laboratory support, participating in the development, implementation, and maintenance of the Branch Quality Management System, and ensuring adherence to applicable guidelines and requirements.

Requirements

Bachelor’s or master’s degree in microbiology, biology, chemistry, or basic medical science
Minimum of 4 years experience specializing in quality management within a regulated scientific environment.
Experience adhering to applicable Quality Management Plan guidelines and requirements. (CLSI, ISO, CLIA, FDA)
Ability to communicate effectively orally and in writing
Strong CAPA, audit, and complaint systems experience is essential
Strong knowledge of established quality and reliability assurance practices, standards, and procedures, their content, and applications as applied to quality systems, manufacturing processes, and production methodology
Strong knowledge of Quality Control (QC) manuals, QC audit procedures, document package requirements, and overall Quality Assurance (QA) criteria specific to inspection reports, parts lists, revision levels, change orders, model numbers, classifications of defects, process test specifications, statistical sampling levels, acceptable quality levels, and others as applicable
Experience using computer software packages including Microsoft Word, Excel, and PowerPoint
Excellent oral and written communication skills in English.
Must be a United States citizen or permanent resident or have authorization for employment in the United States.

Nice To Haves

Comfort working in a fast paced and highly interdisciplinary environment
Experience working with a diverse interdisciplinary team

Responsibilities

Participate in the maintenance of the Branch Quality Management System and adherence to applicable guidelines and requirements established by Clinical Laboratory Improvement Amendments (CLIA), the Food and Drug Administration (FDA) and the International Organization for Standardization (ISO).
Provide direct laboratory support for the implementation of quality system activities, including monitoring equipment calibration and preventive maintenance, coordinating equipment maintenance with vendors, and maintaining records (training, equipment, monitoring records, NCEs etc.) in accordance with quality standards.
Assist laboratories with documentation and investigation of nonconformances.
Monitor competency assessments and proficiency testing.
Work directly with laboratory staff to implement and ensure quality system requirements are met under the direction of the Branch Quality Team.
Assist branch quality team in performing periodic internal quality audits.
Assist branch quality team in development and collation of data for branch quality management reviews.
Work with branch quality team to ensure that all aspects of the branch QMS are developed, documented, implemented, and maintained.
Analyze, review, revise, and/or interpret data and prepare scientific reports, laboratory Standard Operating Procedures (SOPs), training materials, minutes, summary reports, abstracts, manuscripts, presentations, and other documents related to laboratory testing, training, specimen management, safety, and quality.
Assist in placing orders, receiving, and ensuring that packing slips are maintained/uploaded, and all relevant trackers are updated.
Manage in-processing of reagents and supplies, assist in QC and labeling, and with the supplies and reagents inventory.
Assist/manage disposal of expired/hazardous waste.