Quality Assurance Specialist
October 31
Description
• 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.
Requirements
• 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.
Benefits
• Collaborative culture • Competitive salary and benefits • Potential for ownership through stock options
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