Analyst II, QC Raw Materials
Emergent BioSolutions
August 11, 2026
On-site
Canton, MA
Operations
Job Summary:
On-site laboratory testing role responsible for daily testing, quality systems support, and inter-departmental scientific support. Works on complex/varied problems requiring analysis and interpretation.
Responsibilities:
- Sample, label, test, send for external testing, and release incoming raw materials using LIMS.
- Maintain laboratory, equipment, and test methods per approved procedures.
- Drive quality work completion: quality notifications/tasks (deviations, CAPA, change controls, effectiveness checks), and creation/update of documents.
- Perform material qualification tasks (testing, report generation).
- Investigate and determine root cause for laboratory deviations.
- Execute change controls, CAPAs, effectiveness checks, and validation studies (obtain/interpret data).
- Support laboratory operations: LEAN/continuous improvement (5S, Kaizen); GMP-compliant work orders with facilities/metrology; internal audit participation.
- Calibrate instruments; support vendor relations during validation (IOPQ) and calibration.
- Review/verify QC data; author/revise test methods, SOPs, specifications, protocols, technical studies/reports; author investigations/non-conformance.
- Support CAPA and change control via project planning/collaboration.
Required/Preferred Qualifications & Skills:
- Applied science bachelor’s or master’s (chemistry preferred).
- 3–5 years experience preferred (or equivalent).
- Hands-on raw material assay experience in a GMP environment preferred.
- Understanding of cGMP, CFR, and USP required; knowledge of ISO/USP/FDA/EU.
- Proficiency in physical inspection, pH, dimensional analysis, appearance; moderately complex methods (FTIR, titration, UV-Vis) plus spectrophotometry, gel electrophoresis, HPLC, loss on drying.
- Ability to follow written procedures and execute wet chemistry; use LIMS; strong communication; teamwork; MS Office/Excel/Project.
- Personal competencies: self-awareness, integrity, team player, innovative, flexible.
Benefits:
- Comprehensive benefits package (details available via company plan documents).
On-site laboratory testing role responsible for daily testing, quality systems support, and inter-departmental scientific support. Works on complex/varied problems requiring analysis and interpretation.
Responsibilities:
- Sample, label, test, send for external testing, and release incoming raw materials using LIMS.
- Maintain laboratory, equipment, and test methods per approved procedures.
- Drive quality work completion: quality notifications/tasks (deviations, CAPA, change controls, effectiveness checks), and creation/update of documents.
- Perform material qualification tasks (testing, report generation).
- Investigate and determine root cause for laboratory deviations.
- Execute change controls, CAPAs, effectiveness checks, and validation studies (obtain/interpret data).
- Support laboratory operations: LEAN/continuous improvement (5S, Kaizen); GMP-compliant work orders with facilities/metrology; internal audit participation.
- Calibrate instruments; support vendor relations during validation (IOPQ) and calibration.
- Review/verify QC data; author/revise test methods, SOPs, specifications, protocols, technical studies/reports; author investigations/non-conformance.
- Support CAPA and change control via project planning/collaboration.
Required/Preferred Qualifications & Skills:
- Applied science bachelor’s or master’s (chemistry preferred).
- 3–5 years experience preferred (or equivalent).
- Hands-on raw material assay experience in a GMP environment preferred.
- Understanding of cGMP, CFR, and USP required; knowledge of ISO/USP/FDA/EU.
- Proficiency in physical inspection, pH, dimensional analysis, appearance; moderately complex methods (FTIR, titration, UV-Vis) plus spectrophotometry, gel electrophoresis, HPLC, loss on drying.
- Ability to follow written procedures and execute wet chemistry; use LIMS; strong communication; teamwork; MS Office/Excel/Project.
- Personal competencies: self-awareness, integrity, team player, innovative, flexible.
Benefits:
- Comprehensive benefits package (details available via company plan documents).