Guidehouse · 23 hours ago
QA Specialist
US - MD, Bethesda
Full-time
Onsite
Mid Level
$85K/yr - $141K/yr
3+ years expGuidehouse is a leading consulting firm that is currently searching for a Quality Assurance (QA) Specialist to provide support to the National Institutes of Health (NIH). The role involves reviewing records related to the operation of a GMP Quality Control laboratory, maintaining document control systems, and providing QA oversight for various programs and investigations.
AdviceConsultingManagement Consulting
No H1B
Security Clearance Required
Responsibilities
Review records related to the general operation and upkeep of a Good Manufacturing Practice (GMP) Quality Control laboratory, including but not limited to, QC test data, Quality Event (QE) documents, qualification documents, and validations
Receive, log, and release incoming supplies and material to the Quality Control laboratory
Support the maintenance of the document control system, including formatting, numbering, and scanning of records into the Document Management System (DMS)
Support the maintenance of the Equipment Control and Service program, including but not limited to, onboarding of new equipment, maintaining calibration/preventative maintenance records, updating the equipment database, and notifying the laboratory of pending calibration/preventative maintenance activities
Support the maintenance of the CAPA, Deviation, Environmental Excursion, Investigations, and Change Control programs
Support the maintenance of the Internal and External Audit program, with guidance from Management
Track, analyze, and report on Quality Performance Indicators (QPIs)
Provides QA support and oversight for the resolution of CAPA, Deviations, Environmental Excursions, and Change Control
Act as QA reviewer for investigations, deviations, and CAPA; with limited approval authority as designated by QA Management
Participates in Internal Audits to ensure continued adherence to internal procedures and industry best practices
Participate in the GMP training of new employees and contractors, as required
Participates in root cause analysis using methods such as Ishikawa diagrams, 5 Whys, comparative analysis, and process flow charting, as required
Identify and drive system improvements, both within Quality Assurance and for laboratory operations, to effectively accomplish the goals or strategies of the Service and to maximize quality and productivity of the Service
Independently develop, write, and lead the implementation of controlled documents (i.e. SOPs, Policies, Protocols) which may entail significant system changes
Stay current with changes to current Good Manufacturing Practices, as they relate to manufacturing of clinical trial material (Phase 1 – Phase 3), Positron Emission Tomography (PET) drugs, and compounding pharmacies
Follow established policies and procedures and apply applicable regulations based on assignment, such as GMP, CFR, and ICH regulations
Qualification
Required
Bachelor's degree
Minimum of three (3) years of on-the-floor Quality Assurance (QA) experience
Strong communications skills, both oral and written
Excellent analytical, organizational, and time management skills
Ability to rapidly adapt to changing environment and circumstances
Ability to work effectively in a team environment
Preferred
Preferred fields of study: Microbiology, Biological Science, or a related discipline
Knowledge of cGMP, aseptic processing, and Microbiology is strongly preferred but not required
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.)
Position may be eligible for a discretionary variable incentive bonus
Company
Guidehouse
Guidehouse offers consulting services for public and commercial markets with expertise in management, technology, and risk consulting.
10001+ employees
Funding
Current Stage
Late StageTotal Funding
$0.75MKey Investors
Mission Daybreak
2023-11-06Acquired
2023-02-16Grant· $0.75M
Leadership Team
Scott McIntyre
Chairman and CEO
Alicia Harkness
Partner
Recent News
Washington Technology
2026-01-16
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2026-01-09
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