Quality Assurance Specialist

PrognomiQ is developing transformative test products that enable early disease detection and treatment. At PrognomiQ we pride ourselves on our dedication to excellence and innovation.

As we continue to grow, we are seeking a tented Quality Assurance (QA) Specialist to join our team and contribute to the success of our product.

The ideal candidate will have a strong technical background coupled with excellent writing skills. As a QA Specialist, you will be responsible for creating and maintaining comprehensive documentation that outlines quality assurance processes, procedures, and best practices.

You will collaborate closely with R&D, Product Development, and other stakeholders to ensure accuracy and clarity in documentation.

RESPONSIBILITIES

• Writes clear, concise, and comprehensive technical documentation, including test plans, test protocols, work instructions, lab documents by working closely with product development to establish technical procedures that govern the product lifecycle.
• Delivers documentation timely, provide prompt input, and communicate status reports.
• Ensures documentation is organized, accessible, and maintained in a version-controlled environment.
• Develops and optimizes quality systems, tools, data, and processes on an ongoing basis that ensures compliance with established standard operating procedures and regulatory agency guidelines.

Supports the compilation, analysis and reporting of metrics, including identification of trends and / or root cause(s) to help develop new initiatives and process improvements.

• Participates in internal inspection readiness program, providing support at all regulatory inspections and corporate audits, tracking internal / external audit commitments, and driving on time closure, evaluation of new requirements and emerging regulations, and oversight for trending of quality compliance metrics.
• Drives process improvement of quality across all our deliverables.
• Other duties as assigned.

REQUIREMENTS

• Bachelor’s degree in science, English, or related field and / or a combination of practical and educational experience in a regulated industry is required.
• Minimum of 3 years or significant work experience in a regulated environment (ISO, FDA).
• Proficiency in writing clear, concise, and grammatically correct technical documentation.
• Ability to prioritize tasks and manage time effectively in a fast-paced environment.
• Ability to take in technical information and write them to be accessible to all members of the team.
• Proficient knowledge of Microsoft Office, electronic document management and Product Lifecycle Management systems.

Equal Opportunity Employment

PrognomiQ is an equal opportunity employer that celebrates diversity and inclusion in the workplace. We prohibit discrimination and harassment of any kind based on race, color, sex, religion, sexual orientation, national origin, disability, genetic information, pregnancy, or any other characteristic protected by law.

This policy applies to all employment practices within our organization, including hiring, recruiting, promotion, termination, layoff, recall, leave of absence, compensation, benefits, training, and apprenticeship.