QA/QC Specialist

We are currently searching for a Quality Assurance/Quality Control Specialist to provide support to the National Institutes of Health (NIH). This opportunity is a full-time position with MSC, and it is on-site in Bethesda, MD.

• 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.

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• Bachelor’s degree in a science related discipline.
• Minimum of two (2) years of experience in Quality Assurance or Quality Control.
• Knowledge of cGMP, aseptic processing, and Microbiology is strongly preferred but not required.
• Ability to lift 10 – 30 pounds.
• Excellent hand-eye coordination.
• 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.

Due to our contractual requirements and federal orders, including an Executive Order from the White House and an emergency regulation from the Centers for Medicare & Medicaid Services (CMS), the position for which you are applying requires that you provide proof of your vaccination status. If you are unable to receive the COVID-19 vaccine for medical reasons or because of a sincerely held religious belief, you may request an exemption from the vaccination requirement which shall be reviewed after the submission of requested documentation. If an accommodation is granted, the conditions may include weekly testing and masking. All Guidehouse employees also agree to follow any additional health and safety mitigation policies that may be required in the workplace.

Dovel Technologies and its Family of Companies (Medical Science & Computing and Ace Info Solutions) were acquired in October 2021.

Guidehouse is a leading global provider of consulting services to the public sector and commercial markets, with broad capabilities in management, technology, and risk consulting. By combining our public and private sector expertise, we help clients address their most complex challenges and navigate significant regulatory pressures focusing on transformational change, business resiliency, and technology-driven innovation. Across a range of advisory, consulting, outsourcing, and digital services, we create scalable, innovative solutions that help our clients outwit complexity and position them for future growth and success. The company has more than 12,000 professionals in over 50 locations globally. Guidehouse is a Veritas Capital portfolio company, led by seasoned professionals with proven and diverse expertise in traditional and emerging technologies, markets, and agenda-setting issues driving national and global economies.

Guidehouse is an Equal Employment Opportunity / Affirmative Action employer. All qualified applicants will receive consideration for employment without regard to race, color, national origin, ancestry, citizenship status, military status, protected veteran status, religion, creed, physical or mental disability, medical condition, marital status, sex, sexual orientation, gender, gender identity or expression, age, genetic information, 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 accommodation, please contact Guidehouse Recruiting at 1-571-633-1711 or via email at 

Guidehouse does not accept unsolicited resumes through or from search firms or staffing agencies. All unsolicited resumes will be considered the property of Guidehouse, and Guidehouse will not be obligated to pay a placement fee.