Laboratory Quality & Compliance SME

Booz Allen Hamilton•Atlanta, GA

1d•Remote

About The Position

Manage the daily operations of quality and lean activities, including quality system and audits, continuous improvement programs, operational safety, and regulations requirements coordination. Apply specific functional knowledge and working or general industry knowledge. Develop or contribute to solutions to a variety of problems of moderate scope and complexity. Work independently with some guidance.

Requirements

4+ years of experience establishing, maintaining, or improving laboratory quality management systems
1+ years of experience with molecular biology or immunology laboratory techniques
1+ years of experience writing laboratory documents, including SOPs
1+ years of experience assessing laboratory operations and systems for laboratory regulatory compliance
Ability to obtain and maintain a Public Trust or Suitability/Fitness determination based on client requirements
Bachelor's degree

Nice To Haves

Experience with lab quality systems, including CLIA for CMS or HHS, CAP, ISO, GLP, or QSR
Experience with auditing and gap analysis, including writing findings of non-compliance
Experience developing, implementing, and maintaining internal audit schedule and procedures
Experience maintaining governmental regulatory compliance in facilities receiving CMS, CAP, or ISO inspections
Experience managing CAPAs
Experience collecting and analyzing data
Experience with Microsoft suite, including Word, Excel, Teams, PowerPoint, Access, SharePoint, Power BI, and Forms
Experience with Compliance Quest, SmartSolve, MediaLab, or other eQMS systems
ASQ Certification, including CMQ/OE or CQA Certification

Responsibilities

Manage the daily operations of quality and lean activities, including quality system and audits, continuous improvement programs, operational safety, and regulations requirements coordination.
Apply specific functional knowledge and working or general industry knowledge.
Develop or contribute to solutions to a variety of problems of moderate scope and complexity.
Work independently with some guidance.