Laboratory Quality & Compliance SME

Booz Allen Hamilton • Atlanta, GA

3d

About The Position

Laboratory Quality & Compliance SME The Opportunity: 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 in 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
• Manage quality system and audits
• Manage continuous improvement programs
• Manage operational safety
• Manage 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

Benefits

• health
• life
• disability
• financial
• retirement benefits
• paid leave
• professional development
• tuition assistance
• work-life programs
• dependent care

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level