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Quality Assurance (QA) Specialist

Spectraforce Technologies
United States, California, Irvine
Feb 07, 2025
Job Title: Quality Assurance (QA) Specialist Duration: 12 months Location: Irvine CA This position provides assurance of adherence to documentation standards and principles. The role is primarily responsible for managing the creation and revision of Quality System and processes documents including assessment of proposed changes taking all controlled documentation and processes into account. Furthermore, acts as Subject Matter Expert for Quality documentation administration (Change Control) and is the interface between RDQA QS Documentation Management group and supported R&D functions. Key Accountabilities/Core Job Responsibilities: Provides client with understanding of the Quality System and its practical application. Participates in global compliance and continuous improvement projects related to Quality System documentation. Ensures compliance during QS documentation creation and revision and is accountable for content design and logistics of multi- and cross-functional documentation review and approval. Supports development of strategy for creation of complex QS procedural documents involving cross-functional teams. Ensures all administrative documentation requirements are met for supported Quality Documentation inclusive of document processing and records management. Facilitates the creation/revision, administration, review, and approval (as applicable) of new and revised Quality Documentation within the Document Management System (DM) Maintains notifications, relations, and other property information within the Document Management System (DMS). Participates in supporting R&D project and initiatives and continuous improvement projects related to documentation management as applicable. Supports and coordinates of document translation process (incl. Translation checking (LU only) as applicable. Collects and reports documentation-related key performance indicator metrics. Provide input into overall team strategy and framework development for new and emerging initiatives (incl. mid- and long-term team goals). Qualifications (Education and Experience) Bachelor's degree (technical/scientific area preferred) or equivalent experience. Minimum 4+ years of pharmaceutical experience in a GMP environment administering Document Control Systems 1-2 years' experience using and administering electronic document management tools. Specific Skills/Abilities Basic understanding and knowledge of GxP requirements and pharmaceutical regulations preferred. Advanced knowledge and hand-on experience with Document Management Systems OR other database applications Advanced organizational skill, attention to detail Experience with Microsoft Office products, incl MS Word processing / formatting experience Advanced spoken and written English skills (OUS only)) Excellent verbal and written communication and interpersonal skills Strong independent contributor and team member in a fast-paced environment. Ability to work effectively in a team environment. Builds strong relationships with peers and cross-functional partners to enable timeline completion of document lifecycle. Detailed oriented with solid problem-solving acumen.