Laboratory Quality Specialist

ASRT, Inc.; Atlanta (GA); On-site; USD 85,000 - 110,000; Full time

Job summary

ASRT, Inc. provides scientific, information management, management consulting, bioinformatics, and administrative program support to CDC and other clients.

The Laboratory Quality Specialist will support MVPDB at the CDC in Atlanta, focusing on developing, implementing, and maintaining the Branch Quality Management System. You will work with laboratory staff to ensure quality system requirements are met, perform internal audits, analyze data, prepare SOPs and training materials, and manage

Qualifications

• 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 CLSI, ISO, CLIA, FDA guidelines.
• Excellent oral and written communication skills in English.

Responsibilities

• Maintain the Branch Quality Management System in line with CLIA, FDA and ISO guidelines.
• Provide direct lab support for quality system activities and records.
• Coordinate equipment maintenance and calibration with vendors.
• Assist laboratories with documentation and investigation of nonconformances.
• Monitor competency assessments and proficiency testing.
• Assist in internal quality audits and data collation for reviews.
• Develop and update SOPs, training materials, and reports.

Skills

Communication

CAPA & audits

Regulatory knowledge

Documentation & record-keeping

Education

Bachelor's or Master's in microbiology/biology/chemistry/basic medical science

Tools

Microsoft Word

Microsoft Excel

PowerPoint

Job description

Description

JOB TITLE: Laboratory Quality Specialist

POSITION NUMBER: 2609-20261-LQS-001

POSITION LOCATION: Atlanta, GA, USA

ANTICIPATED START DATE: Three to six weeks after candidate identification

TRAVEL: As required to fulfill the responsibilities of the position

ASRT, Inc. provides scientific, information management, management consulting, bioinformatics, and administrative program support to the Centers for Disease Control and Prevention (CDC) and other Federal and private sector clients. The successful candidate will be a full-time employee of ASRT, Inc. and will be assigned to the Meningitis and Vaccine Preventable Diseases (MVPDB), National Center for Immunization and Respiratory Diseases (NCIRD), at the CDC, 1600 Clifton Road, Atlanta, GA, to support to the Bacterial Meningitis Laboratory (BML), Quality Management team and M&O team within MVPDB.

SCOPE OF WORK

The Laboratory Quality Specialist will provide scientific and laboratory support within the MVPDB, providing support services participate in the development, implementation, and maintenance of the Branch Quality Management System, as well as adherence to applicable guidelines and requirements

MAJOR DUTIES AND 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:

1. Monitor equipment calibration and preventive maintenance activities.
2. Coordinate equipment maintenance with vendors as applicable.
3. Maintain records (training, equipment, monitoring records, NCEs etc.) in accordance with quality standards.
4. Assist laboratories with documentation and investigation of nonconformances.
5. Monitor competency assessments and proficiency testing.

• Under the direction of the Branch Quality Team, work directly with laboratory staff to implement and ensure quality system requirements are met.
• 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 the 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.

Requirements

MINIMUM QUALIFICATIONS

Education and Experience:

• 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.

Required:

• 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

Desirable:

• Excellent oral and written communication skills
• Comfort working in a fast paced and highly interdisciplinary environment
• Experience working with a diverse interdisciplinary team

Language Skills:

• The candidate must possess excellent oral and written communication skills in English.

REQUIREMENT: Must be a United States citizen or permanent resident or have authorization for employment in the United States.

SALARY: Commensurate with qualifications and experience.