Quality Assurance Specialist - Rockville, MD

ICON Government and Public Health Solutions (IGP) is seeking a Quality Assurance Specialist to join our team to support the National Institute of Allergy and Infectious Diseases (NIAID).

Responsibilities:

• 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.

Qualifications:

Education:

• Bachelor’s degree in a science related discipline..

Experience:

• 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.
• Work will be performed on a varied schedule per week and includes weekends, holidays, etc. as well as on-call.
• Must be a US Citizen
• Ability to obtain a Level 5: Public Trust
• Location: Rockville, MD (sponsor)

***Contingent upon contract award***

Why ICON?

Our focus is to provide you with a comprehensive and competitive total reward package that comprises, not only an excellent level of base pay, but also a wide range of variable pay and recognition programs. In addition, our best in class employee benefits, supportive policies and wellbeing initiatives are tailored to support you and your family at all stages of your career - both now, and into the future.

Our success depends on the knowledge, capabilities and quality of our people. That’s why we are committed to developing our employees in a continuous learning culture – one where we challenge you with engaging work and where every experience adds to your professional development.

ICON, including subsidiaries, is an equal opportunity and inclusive employer and is committed to providing a workplace free of discrimination and harassment. All qualified applicants will receive equal consideration for employment without regard to race, colour, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.

If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or in order to perform the essential functions of a position, please let us know.

Interested in the role, but unsure if you meet all of the requirements? We would encourage you to apply regardless – there’s every chance you’re exactly what we’re looking for here at ICON whether it is for this or other roles.

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