BostonGene Technologies

Индустрия: Информационные технологии

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QA Coordinator - Lab Operations Support

По эл. почте

Крайний срок: 19 Май 2024

Условия контракта: Постоянный

Категория: Обеспечение/контроль качества

Тип вакансии: Полная ставка

Местонахождение: Ереван

Описание работы

BostonGene is seeking a QA Coordinator to join our Quality Assurance team. This position will report to the Quality Systems Manager. The position will focus on various Quality Management System (QMS) activities, specifically document control, records management, and change control for Pre-Analytic, Analytical, and Post-Analytic teams.

Обязанности

Administer BostonGene’s electronic document management system.
Reviewing, routing, uploading, archiving, and distributing documents, records, and QMS training assignments.
Provide guidance and ensure compliance with Document Control, Change Control, Training, and Records Management processes.
Participate in Quality Improvement Activities as a representative of the Quality department.
Quality Assurance review of reports and data for Good Documentation Practices (GDP); ensure issues are corrected, if necessary.
Monitors, administers and reports on the status and stages of various documents within the document control system.
Maintain the organization and accessibility of clinical documents used throughout the organization by regulatory requirements.
Participation in internal audits, client or sponsor audits, personnel training files audits, and trending/reporting of quality metrics.
Support regulatory compliance efforts.
Other duties as assigned.

Требования

Bachelor’s degree or equivalent working experience.
1-2 years of working experience in a Quality, Regulatory, Document Control, Training, or Records Management role in a Life science, Medical Device, Pharmaceutical, or similar regulated industry.
Must be familiar with the use of electronic document management systems.
Knowledge of regulatory requirements or standards such as CAP/CLIA, ISO 13485, ISO 15189, or Good Clinical Lab Practice (GCLP) is a plus.
Strong communication skills, both oral and written in English and Russian.
Focus and attention to detail is critical.
Ability to apply complex document control processes to work assignments and organize/prioritize to meet timelines.

Требуемый уровень кандидата: Средний уровень

Дополнительная информация

We offer:

The office is located in Yerevan, within a 1-minute walk from the metro.
Complete documentation and bureaucracy support on-site (bank accounts, residence permit, school contacts, etc.).
Full-time position, permanent contract, flexible working hours, hybrid work.
Competitive salary.
Healthcare insurance, corporate plans for English language lessons, and gym.
Versatile professional environment: bioinformatics, biologists, physicians, and software developers who united to save people’s lives.

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