| Quality Systems Specialist III Change Control - Foster City, CA onsite 3 days a week at Foster, Rhode Island, USA |
| Email: [email protected] |
| From: prashanth, AcuBahn Inc. [email protected] Reply to: [email protected] Job Title : Quality Systems Specialist III Change Control Local to Bay Area (Foster City, CA) and onsite 3 days/week Biologics experience is a must. Prefer Veeva QMS experience but not required. Department Quality, Policies and Systems (QPS) Job Responsibilities Responsible for managing change controls related to manufacturing product, process, equipment, facility, and computerized systems contributing to the oversight of key strategic, tactical, and operational goals. Independently review, initiate, complete, and thoroughly document critical, major, and minor change controls, managing local and global change controls and associated activities related to GxP operations. Facilitate cross-functional meetings with stakeholders and leadership to ensure alignment with proposed changes and compliance to QMS expectations. Navigate through complex change review discussions, facilitating to a common decision for each change regarding approach and follow-up actions to be taken, and documenting the decisions and evaluations accordingly. Supports management and monitoring of change records for adherence to organizational or departmental metric targets, and maintenance of associated tracking tools/databases. Supports management review process through development and generation of quality system metrics and trending, and escalates issues as required. Supports the maintenance and improvement of quality systems processes, as needed. Works directly with operating entities and internal clients to ensure follow-up of change tasks. Participate in compliance audits as required. Maintains programs and processes to ensure high quality products and compliance with current Good Manufacturing Practices (cGMPs). Writes and/or implements changes to controlled documents (e.g., SOPs, Specifications, Methods, etc.) as needed. Provides guidance and technical knowledge to more junior staff, monitors the performance of daily tasks. Knowledge & Skills Will need to demonstrate the ability to manage multiple change controls of varying complexity and scope of tasks in a fast-paced environment to meet timelines. Demonstrates proficiency in Good Manufacturing Practices (GMPs) Demonstrates proficiency in application of QA systems principles, concepts, industry practices, and standards. Demonstrates thorough knowledge of FDA / EMEA standards and quality systems, and the interface with other functions like manufacturing, distribution and maintenance. Demonstrates Project Management abilities to lead and manage several projects, meeting deadlines and use critical thinking skills to problem solve effectively. Demonstrate strong scientific/technical understanding of small and/or large biologic molecule operations and related regulations/guidelines. Demonstrates knowledge of Six Sigma andLEAN concepts, and risk management tools for assessing change impact. Demonstrate knowledge and application of risk management principles, including identification, controls, mitigations, and actions. Demonstrates excellent verbal and written communication skills to all levels of the organization. Technical writing Skills required. Demonstrate ability to problem solve and lead process improvements. Demonstrate ability to lead cross-functional meetings and make decisions as QA representative. Demonstrates strong interpersonal skills with ability to influence, negotiate, manage conflict, and negotiate. Demonstrates proficiency in Microsoft Office applications. Education and Experience 6+ years of relevant experience in a GMP environment for biologics manufacturing and a BS or BA, with change control experience a must. 4+ years of relevant experience and a MS. Keywords: quality analyst business analyst microsoft California |
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| Tue Mar 19 19:10:00 UTC 2024 |