QA Regulatory Data SME

🔥 0 minutes ago

🦀 Maryland – Remote

🦀 Maryland – Remote

💵 $85k - $141k / year

⏰ Full Time

🟡 Mid-level

🟠 Senior

🔧 QA Engineer (Quality Assurance)

🦅 H1B Visa Sponsor

This company has sponsored H1B visas in the past.

Apply Now

Find Similar Remote Jobs

Receive Emails For Remote Jobs

📊 Check your resume score for this job

Improve your chances of getting an interview by checking your resume score before you apply.

Upload Resume

Guidehouse

WebsiteLinkedInAll Job Openings

10,000+ employees

Founded 2018

💰 Grant on 2023-02

Consulting • Digital Services • Public Sector

Guidehouse is a global consultancy offering advisory, digital, and managed services across commercial and public sectors. It is purpose-built to support industries such as national security, financial services, healthcare, energy, and infrastructure. Guidehouse collaborates with leaders to navigate complexity and drives transformational changes that impact the future. Their expertise spans data analytics, digital technologies, risk management, and more, with a strong emphasis on sustainability and innovation.

📋 Description

• Perform comprehensive reviews of database records to evaluate completeness, accuracy, and consistency • Analyze variations in sampling and testing procedures and assess impacts to data quality and integrity across data sources. • Assess compliance of documentation and data controls with FDA regulations, guidance, and standard operating procedures • Evaluate completeness, and consistency and gaps in supporting documentation associated with testing activities • Identify deviation, inconsistencies from established processes and risks impacting regulatory decisions; Provide prioritized, actionable recommendations for corrective and preventive actions (CAPA) • Support alignment of database practices with regulatory expectations and audit standards • Prepare a comprehensive final audit report detailing observations, risk areas, and root causes • Present findings and recommendations to stakeholders across regulatory, scientific, and program leadership teams • Support implementation planning for process improvements and data governance enhancements

🎯 Requirements

• Bachelor’s Degree in Chemistry, Pharmaceutical Sciences, Regulatory Science, Data Science, or related discipline • Minimum five (5) years of relevant experience in regulatory data analysis, quality assurance, or FDA-regulated environments • Demonstrated ability to define problems and analyze complex systems within regulatory or scientific domains • Experience developing analysis plans, evaluating data quality, and supporting regulatory decision-making processes • Experience coordinating and managing analytical evaluations, audits, or compliance reviews • Strong knowledge of FDA regulations, data integrity principles (e.g., ALCOA+), and laboratory documentation standards • Ability to assess system specifications and recommend improvements for implementation • Excellent written and verbal communication skills, including status reports, technical reports and audit documentation • Strong critical thinking and problem-solving capabilities in complex regulatory environments.

🏖️ Benefits

• Medical, Rx, Dental & Vision Insurance • Personal and Family Sick Time & Company Paid Holidays • Parental Leave • 401(k) Retirement Plan • Group Term Life and Travel Assistance • Voluntary Life and AD&D Insurance • Health Savings Account, Health Care & Dependent Care Flexible Spending Accounts • Transit and Parking Commuter Benefits • Short-Term & Long-Term Disability • Tuition Reimbursement, Personal Development, Certifications & Learning Opportunities • Employee Referral Program • Corporate Sponsored Events & Community Outreach • Care.com annual membership • Employee Assistance Program • Supplemental Benefits via Corestream (Critical Care, Hospital Indemnity, Accident Insurance, Legal Assistance and ID theft protection, etc.)