Quality Assurance Manager, Sterility Testing
Apply Job ID 31549 Date posted 08/14/2025Job Family:
Scientific Research & Analysis (Digital)
Travel Required:
Clearance Required:
We are currently searching for a Quality Assurance (QA) Manager. This is a full-time, on-site opportunity based in Bethesda, MD.
What You Will Do:
Provide QA leadership and team management for the laboratory’s Sterility Testing Service to ensure cGMP compliance with FDA regulations.
Provide oversight of Quality Management System including document management system (MasterControl), equipment management system, material management system, quality event tracking system, internal and external audit program. Institute new electronic programs/systems to streamline workflow of quality management systems.
Participate in project management for the construction of the new HVAC system. Oversight of QA activities pertaining to materials, equipment validation, facility CQV, preparation for audits, training program, development of new SOPs.
Assist leadership in identifying critical pain points for the cGMP program. This includes forecasting for space requirements, personnel requirements, operation requirement, QA requirements, equipment requirements.
Participate in program management of onboarding new global cGMP programs including a laboratory information management system and automated environmental monitoring.
Review records related to the general operation and upkeep of a 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, on-boarding 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.
Participate in the teaching program of clinical fellows rotating through the Sterility Testing Service.
Effectively lead and provide oversight of a team of QA Specialists.
What You Will Need:
Bachelor’s Degree in a science-related discipline.
Minimum of SIX (6) years in a laboratory environment
Minimum of TWO (2) years of experience in Quality Assurance or Quality Control.
Minimum of TWO (2) years of experience effectively lead and provide oversight of a team of QA Specialists
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.
Ability to lift 10 – 30 pounds.
Excellent hand-eye coordination.
Must be able to OBTAIN and MAINTAIN a Federal or DoD "PUBLIC TRUST"; candidates must obtain approved adjudication of their PUBLIC TRUST prior to onboarding with Guidehouse. Candidates with an ACTIVE PUBLIC TRUST or SUITABILITY are preferred.
What Would Be Nice To Have:
Knowledge of cGMP, aseptic processing, and Microbiology is strongly preferred.
What We Offer:
Guidehouse offers a comprehensive, total rewards package that includes competitive compensation and a flexible benefits package that reflects our commitment to creating a diverse and supportive workplace.
Benefits include:
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
About Guidehouse
Guidehouse is an Equal Opportunity Employer–Protected Veterans, Individuals with Disabilities or any other basis protected by law, ordinance, or regulation.
Guidehouse will consider for employment qualified applicants with criminal histories in a manner consistent with the requirements of applicable law or ordinance including the Fair Chance Ordinance of Los Angeles and San Francisco.
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