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.

Salary at Booz Allen is determined by various factors, including but not limited to location, the individual’s particular combination of education, knowledge, skills, competencies, and experience, as well as contract-specific affordability and organizational requirements. The projected compensation range for this position is $55,200.00 to $126,000.00 (annualized USD). The estimate displayed represents the typical salary range for this position and is just one component of Booz Allen’s total compensation package for employees. This posting will close within 90 days from the Posting Date.

Identity Statement

As part of the application process, 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.

Work Model
Our people-first culture prioritizes the benefits of flexibility and collaboration, whether that happens in person or remotely.

• If this position is listed as remote or hybrid, you’ll periodically work from a Booz Allen or client site facility.
• If this position is listed as onsite, you’ll work with colleagues and clients in person, as needed for the specific 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.