Quality Assurance Manager, Sterility Testing

Quality Assurance (QA) Manager

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 :

What Would Be Nice To Have :

The annual salary range for this position is $130,000.00-$216,000.00. Compensation decisions depend on a wide range of factors, including but not limited to skill sets, experience and training, security clearances, licensure and certifications, and other business and organizational needs.

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 :

Guidehouse is an Equal Opportunity EmployerProtected 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.

If you have visited our website for information about employment opportunities, or to apply for a position, and you require an accommodation, please contact Guidehouse Recruiting at 1-571-633-1711 or via email at RecruitingAccommodation@guidehouse.com . All information you provide will be kept confidential and will be used only to the extent required to provide needed reasonable accommodation.

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