This role will be responsible for: Qualification of GMP equipment and associated compliance documentation, writing qualification protocols, working with QA to obtain protocol approval, and executing validation activities. Manage equipment lifecycle activities and documentation such as system risk assessments, decommissioning, and periodic review; serving as department SME for data migration and archival; initiating, planning, and implementing Change Control records as Change Owner as needed; and supporting GMP audits as equipment validation and compliance SME. The specialist will work with vendors to provide instrument maintenance and troubleshooting and in-lab equipment and facility support, and act as the deputy lab manager as needed. The successful candidate will work in a highly collaborative environment to utilize their technical and communication skills in partnership with analytical chemists and QA to solve complex challenges in SMAC. Hands-on experience and knowledge of technologies such as HPLC, GC, MS, KF, spectroscopy, dissolution and related software will be used to support the daily operations and GMP compliance of our state-of-the-art analytical labs and instruments. Who You Are BS in Chemistry or relevant disciplines in a technical field with a 2-8 years relevant experience in the pharmaceutical/biotech industry Hands-on experience in GMP equipment qualification, life-cycle management, and compliance documentation Good understanding of cGMP compliance, quality assurance, change control, data integrity, and good documentation practices Broad knowledge and experience with analytical instrumentation (HPLC, GC, MS, KF, spectroscopy, dissolution, etc.) including regular maintenance and troubleshooting Demonstrated learning agility, adaptability, collaborative skills and delivering results through teamwork Proactive and effective communication with client groups Leadership skills in identifying opportunities and taking initiatives to improve systems, processes, and workflows Excellent organizational skills and attention to detail Preferred Knowledge of Empower software and IT support of data systems is preferred
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