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.

You Have:

• 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 If You Have:

• 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

Vetting:

Applicants selected will be subject to a government investigation and may need to meet eligibility requirements of the U.S. government client.

Compensation

At Booz Allen, we celebrate your contributions, provide you with opportunities and choices, and support your total well-being. Our offerings include health, life, disability, financial, and retirement benefits, as well as paid leave, professional development, tuition assistance, work-life programs, and dependent care. Our recognition awards program acknowledges employees for exceptional performance and superior demonstration of our values. Full-time and part-time employees working at least 20 hours a week on a regular basis are eligible to participate in Booz Allen's benefit programs. Individuals that do not meet the threshold are only eligible for select offerings, not inclusive of health benefits. We encourage you to learn more about our total benefits by visiting the Resource page on our Careers site and reviewing Our Employee Benefits page.

Identity Statement

As part of the hiring process, we will ask you to complete an identity verification process that leverages advanced biometrics and artificial intelligence to ensure authenticity and protect against identity fraud. You are expected to be on camera during interviews and assessments. We reserve the right to take your picture to verify your identity and prevent fraud.

Candidate AI Usage Policy

AI is a part of our daily work at Booz Allen, and we are committed to the responsible and ethical use of AI tools. However, we want to ensure a fair candidate process based on your own skills and knowledge. As part of this commitment, the use of artificial intelligence (AI) or other tools to assist with responses during interviews (whether in-person or virtual) is prohibited unless permission is explicitly provided.

Work Model
Our people-first culture prioritizes the benefits of collaboration, whether it occurs in person or virtually. To support engagement and effective communication, employees working virtually are generally expected to have their cameras on during meetings.

• Remote: If this position is listed as remote, there may still be occasions when you are required to work in person at a Booz Allen or customer facility.

• Hybrid: If this position is listed as hybrid, you will be expected to work from a Booz Allen facility frequently, in alignment with leadership expectations and the needs of the role. You may also be required to work from or visit a customer facility.

• Onsite: If this position is listed as onsite, work will primarily be performed at a Booz Allen office or customer facility, where employees will collaborate directly with colleagues and customers as required by the role.

Commitment to Non-Discrimination

All qualified applicants will receive consideration for employment without regard to disability, status as a protected veteran or any other status protected by applicable federal, state, local, or international law.