Trabajos a distancia y desde casa en Remote - Boston Metro Region ∙ Página 1

Our Opportunity…

We’re looking for a motivated, experienced, purpose driven Quality Assurance Specialist Contractor to plan, coordinate, and execute a critical project to support compliance with all regulatory requirements. As part of our Quality Assurance team, you’ll be a vital part of a highly collaborative team working to achieve Obsidian’s vision by translating innovative science into medical breakthroughs for patients, starting with our lead program OBX-115.

This is a remote role; candidates within driving distance to our Bedford, MA location are preferred for easy access for on-site meetings if warranted.

You Will…

• Provide QA support for the migration of a variety of controlled quality documents into Obsidian document repository.
• Review existing quality, analytical, process, and manufacturing SOPs and associated documents and reports and properly and accurately label for future migration activities.
• Create searchable metadata to easily find and retrieve documents for future use.
• Collaborate with IT, QA, Analytical Development, Process Development, and other key partners.
• Contribute to continuous improvements of department processes.
• Assist with improvement of Quality Systems, including but not limited to internal document review, change controls, deviations, investigations, and review of batch records.

 You Bring…

Core Qualifications

• Bachelor’s degree in biology, chemistry, engineering, life sciences or a related field, and 3+ years of relevant work experience (or M.S. and 1+ years of relevant work experience).
• Understanding of GMP requirements and best practices in drug development.
• Experience with QA document control and management and Quality Systems.
• Experience with management of controlled documents such as SOPs, manufacturing batch records, test records, deviations, CAPAs, and other quality records.
• Experience with both paper and electronic QMS systems.
• Strong command of SharePoint and labeling of quality documents.
• Strong knowledge of GMP, SOPs, and quality system processes.
• A team mindset and highly collaborative working style.
• Ability to communicate effectively with scientific/technical colleagues, and effectively collaborate in a dynamic, cross-functional environment.
• Ability to manage and deliver multiple projects in a fast-paced environment.
• A systems thinker. Approaches problem solving and process design from with consideration of the overall system as well as its individual parts; considers interrelationships and patterns.
• Demonstrates context-based sound judgement.

Bonus Qualifications

• Experience in cell therapy or biologics.
• Familiarity with FDA and EMA guidance documents relevant to gene and cell therapy analytical development and method validation.
• Contribution to the implementation of an electronic QMS system.
• Quality systems experience (Trackwise, Veeva, SAP CAPA, Documentum etc.).