QC Specialist
Posted 17 Sep 2026
Advertised as “QC Specialist II/III - Chemistry”
BranchFactor Summary
The original posting with the fluff stripped out
- Expected experience
- 1–4 yrs
- Management level
- Individual contributor
- Employment
- On-Site
No salary listed for this role.
Field of studyChemistry
Study levelBachelor's or higher
The Quality Control Specialist – Chemistry is responsible for providing support for analytical instrumentation support used within the Quality Control Chemistry Laboratory. This role serves as a technical expert, ensuring instrument specifications meet method requirements, providing troubleshooting, and ensuring data integrity meet regulatory expectations (FDA, ICH, JP).
Responsibilities
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Oversee chemistry laboratory instruments, including HPLC, UPLC, GC, LC-MS, UV-Vis, FTIR, dissolution systems, Particle Size Analyzers, and other analytical instrumentation.
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Author, update, and maintain user requirement specifications for new and existing laboratory instruments.
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Create and maintain risk decision records to support instrument purchasing decisions.
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Author, review, and maintain instrument risk assessments to ensure compliance and proper risk control.
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Create and maintain instrument documentation throughout the lifecycle, including updates to methods or instrument procedures driving by changes, CAPAs, or new requirements
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Develop training materials and deliver instrument-specific training to analysts and team members.
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Assist analysts with instrument troubleshooting, escalating issues appropriately, and submitting instrument work orders for the laboratory analysts.
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Identify opportunities to improve instrument reliability, documentation quality, and training effectiveness.
SKILLS/COMPETENCIES:
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Strong understanding of instrument operation, troubleshooting, and lifecycle management
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Experience authoring technical documentation (URS, Risk Assessments, SOPs, etc)
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Ability to deliver clear, structured technical training
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Familiarity with QC systems (Empower, LIMS, TrackWise)
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Strong problem-solving and risk-assessment skills
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Ability to collaborate across functions and communicate technical concepts clearly.
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Strong understanding of data integrity and compliance regulations
PERSONAL ATTRIBUTES:
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Ability to work hard and contribute to an enjoyable rapidly changing working environment
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Proactively achieves results for the best of the organization
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Willingness to learn new things