Senior Specialist I/II, Analytical Instrument and Systems Qualification

Position Overview:

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.

Primary Responsibilities:

• 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.
• Define and verify data integrity and computerized system controls per DIAS (e.g., access management, audit trails, e‑records/e‑signatures, backup/recovery, calculations, data flows/interfaces) for instruments with embedded or attached control software.
• Initiate and/or execute change controls for instrument configuration changes, software upgrades, relocations, and method impacts; perform impact assessments and define re‑qualification needs.
• Perform/participate in periodic validation maintenance reviews to confirm lifecycle documents (SIA, URS, DIAS, CS, FDS, RTM, QSR) remain current and that assets stay in a validated state.
• Partner with QC SMEs, Digital Quality & Data Integrity, Validation, QA, IT, Facilities/Metrology, and vendors to plan and deliver qualification on schedule; coordinate service/vendor activities for installation, calibration, and PM in support of qualification and sustainment.
• Support internal/external audits and health authority inspections as the qualification/validation point of contact for assigned instruments, providing rationales, traceability, and documented evidence.
• Lead or support investigations and CAPAs related to instrument performance, data integrity, or qualification gaps, ensuring timely closure and documented effectiveness checks.

Qualifications:

• Bachelor’s or Master’s degree required, preferably in a life science discipline with 10-12 years’ experience.
• 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. Technical writing skills.
• Ability to work independently in a high-paced team environment, meet deadlines, and prioritize work from multiple projects.
• Advanced ability to communicate effectively with peers, department management and cross-functional peers.
• Documentation Excellence: Clear, complete, and audit‑ready authorship of URS, SIA, DIAS, CS, FDS, protocols, RTM, and QSR.
• Systems Thinking: Ability to define system boundaries, dependencies, and data flows; translate requirements into testable specifications and traceability.
• Quality Mindset: Applies risk‑based, phase‑appropriate validation; maintains validated state through disciplined change control and periodic review.
• Collaboration & Influence: Works effectively with QA/Validation/IT/Digital Quality & Data Integrity, lab users, and vendors to resolve issues and meet milestones.