Analyst II, QC Raw Materials
Emergent BioSolutions
September 02, 2026
On-site
Canton, MA
Operations
Job Summary
- On-site laboratory testing position with responsibilities in daily testing, quality systems support, and inter-departmental scientific support.
- Works on complex, varied problems/projects requiring in-depth analysis and interpretation.
Role Responsibilities / Essential Functions
- Sample, label, test, send for external testing, and release incoming raw materials using LIMS.
- Maintain laboratory, equipment, and test methods per approved procedures.
- Drive to completion quality notifications/tasks (deviations, CAPA, change controls, effectiveness checks), and create/update documents.
- Perform material qualification tasks (testing, report generation).
- Execute laboratory tests to ensure timely delivery of results to internal and external customers.
- Investigate and determine root cause for laboratory deviations.
- Execute change controls, CAPAs, effectiveness checks, and validation studies; obtain and interpret validation data.
- Maintain laboratory equipment per established procedure; perform instrument calibration.
- Initiate continuous improvement using Lean (5S, Kaizen).
- Conduct/document work orders with facilities/metrology to support GMP-compliant lab/equipment state.
- Support and/or lead internal audit activities under GMP; participate as QC lead/support; may guide lower-level personnel.
- Represent QC in vendor relations; support vendor validation (IOPQ) and calibration.
- Review and verify QC data.
- Author/revise test methods, SOPs, specifications, and technical studies/reports; author lab investigations and non-conformance; support CAPA/change control planning/collaboration.
Minimum Education / Experience / Skills
- Bachelor’s or master’s degree in applied science (chemistry preferred).
- 3–5 years of experience preferred (or equivalent).
- Preferred: hands-on raw material assays in a GMP environment.
- Required: understanding of cGMP, CFR, USP.
- Required: good written/verbal communication and teamwork; computer skills (MS Office/Excel/Project or equivalents).
- Required proficiency/compliance awareness (ISO, USP, FDA, EU) and ability to follow written procedures incl. wet chemistry.
- Experience using LIMS.
- Technical methods: physical inspection, pH, dimensional analysis, appearance; FTIR, titration, UV-Vis; spectrophotometry, gel electrophoresis, HPLC, loss on drying.
Application Instructions
- If selected for an interview, speak to a Human Resources Partner about compensation philosophy and available benefits.
- On-site laboratory testing position with responsibilities in daily testing, quality systems support, and inter-departmental scientific support.
- Works on complex, varied problems/projects requiring in-depth analysis and interpretation.
Role Responsibilities / Essential Functions
- Sample, label, test, send for external testing, and release incoming raw materials using LIMS.
- Maintain laboratory, equipment, and test methods per approved procedures.
- Drive to completion quality notifications/tasks (deviations, CAPA, change controls, effectiveness checks), and create/update documents.
- Perform material qualification tasks (testing, report generation).
- Execute laboratory tests to ensure timely delivery of results to internal and external customers.
- Investigate and determine root cause for laboratory deviations.
- Execute change controls, CAPAs, effectiveness checks, and validation studies; obtain and interpret validation data.
- Maintain laboratory equipment per established procedure; perform instrument calibration.
- Initiate continuous improvement using Lean (5S, Kaizen).
- Conduct/document work orders with facilities/metrology to support GMP-compliant lab/equipment state.
- Support and/or lead internal audit activities under GMP; participate as QC lead/support; may guide lower-level personnel.
- Represent QC in vendor relations; support vendor validation (IOPQ) and calibration.
- Review and verify QC data.
- Author/revise test methods, SOPs, specifications, and technical studies/reports; author lab investigations and non-conformance; support CAPA/change control planning/collaboration.
Minimum Education / Experience / Skills
- Bachelor’s or master’s degree in applied science (chemistry preferred).
- 3–5 years of experience preferred (or equivalent).
- Preferred: hands-on raw material assays in a GMP environment.
- Required: understanding of cGMP, CFR, USP.
- Required: good written/verbal communication and teamwork; computer skills (MS Office/Excel/Project or equivalents).
- Required proficiency/compliance awareness (ISO, USP, FDA, EU) and ability to follow written procedures incl. wet chemistry.
- Experience using LIMS.
- Technical methods: physical inspection, pH, dimensional analysis, appearance; FTIR, titration, UV-Vis; spectrophotometry, gel electrophoresis, HPLC, loss on drying.
Application Instructions
- If selected for an interview, speak to a Human Resources Partner about compensation philosophy and available benefits.