Senior Specialist, Quality Control

Role: Senior Specialist in Quality Control providing technical expertise in equipment maintenance, calibration, and process improvements within a biopharma setting. Responsibilities include managing analytical instrumentation, overseeing equipment qualification and change control, maintaining compliance with FDA and GMP standards, and supporting digital systems like Empower and GLIMS. The position involves troubleshooting, vendor management, and participating in quality investigations and audits. Requirements: Bachelor’s in Chemistry, Biology, or Engineering; ≥4 years in a pharmaceutical lab; proficiency with Empower chromatography software, SAP/EAM, and analytical instruments such as HPLC, GC, and KF. Preferred skills include experience as a site Empower CDS coordinator, managing vendor relations, and familiarity with regulatory and quality standards. High-value specifics: focus on analytical equipment, GMP compliance, change control, equipment validation, and digital system management in a regulated lab environment. Collaboration includes liaising with internal teams, external vendors, and supporting quality systems. Work setup: on-site with 10% travel; position start anticipated January 2027.