Senior Specialist I/II, Analytical Instrument and Systems Qualification

Working understanding of various analytical techniques primarily flow cytometry, plate based assays, automated liquid handling, liquid chromatography, capillary electrophoresis, and next generation sequencing.

Experience qualifying and sustaining a range of QC instruments (e.g., HPLC/UPLC, GC, CE, UV‑Vis, FTIR, TOC, qPCR/plate readers, balances, pH meters, osmometers, NGS, Flow Cytometers), including networked data systems and interfaces.

Working knowledge of applicable regulatory expectations for e‑records/e‑signatures and computer systems (e.g., Part 11/Annex 11), with successful inspection support.

Experience collaborating across multi‑site QC organizations and with equipment vendors to deliver validation to plan.

Systems Thinking: Ability to define system boundaries, dependencies, and data flows; translate requirements into testable specifications and traceability.

Collaboration & Influence: Works effectively with QA/Validation/IT/Digital Quality & Data Integrity, lab users, and vendors to resolve issues and meet milestones.

The Quality Control (QC) Specialist I/II—Analytical Instrument Qualification is responsible for the end‑to‑end onboarding, qualification, and lifecycle management of analytical instruments used in both Massachusetts and North Carolina GMP testing laboratories.

The role authors and/or reviews core validation deliverables (URS, SIA, DIAS, CS, FDS), plans and executes risk‑based qualification (IQ/OQ/IOQ/PQ), maintains traceability, and ensures assets remain in a validated state through structured change control and periodic validation maintenance.

Work is executed in accordance with internal procedures and associated work instructions/templates in Beam Quality Management System with specific attention to embedded software/data integrity expectations.

Lead or support onboarding of new analytical instruments, defining system boundaries, intended use, and qualification strategy in alignment with SIA and URS, including Draft, review, and secure approval of URS, SIA, DIAS, CS, and FDS deliverables.

Author and execute IQ/OQ/IOQ/PQ protocols (as appropriate), ensuring test pre‑requisites, evidence, and deviations are documented and resolved prior to release for GMP use.

Build and maintain the Requirements Traceability Matrix (RTM) to link requirements (URS/DIAS/CS/FDS) through protocol test cases and results; compile a Qualification Summary Report (QSR) to close projects.