Analyst III, QC Raw Materials
Emergent BioSolutions
August 11, 2026
Remote friendly (Canton, MA)
United States
Operations
Job Summary
- Perform methods and procedures for inspecting, testing, and evaluating raw materials.
- Support program improvements including SOPs, new test methods, improved specifications, raw material qualification program, and alignment of raw material procurement with other sites.
- Streamline and improve compliance and efficiency in Quality Control programs; develop, implement, and maintain QC quality control systems and activities.
- Conduct out-of-specification (OOS) and failure investigations; recommend and implement corrective actions.
- Responsible for tracking and completion of quality investigations and compliance records for the QC department.
Essential Functions
- Support implementation of the raw material program at EMOB.
- Lead change for revision of existing tests and development of new assays in accordance with internal processes, compendial requirements, and GxP.
- Assess compendial changes; revise assays and identify need for new assay development.
- Perform daily routine sampling and testing of raw materials; perform lab cleaning (weekly/monthly).
- Use analytical/compendial methods: FTIR, pH measurement, refractometry, density/specific gravity (density meter), UV-VIS, distillation, titrations, AKTA, HPLC, GC.
- Enter sample and result data into LIMS Lab Vantage; perform data analysis and prepare results for review.
- Ship samples; monitor contract lab test results; coordinate with third parties and manufacturers to implement testing methodologies.
- Prepare specifications, SOPs, method verification protocols/reports; support equipment qualification, calibration, preventive maintenance.
- Lead Period Review, OOS, deviations, Change Control, and CAPAs; design/implement corrective action plans.
Qualifications / Requirements
- Bachelor’s in Chemistry or related field with 5+ years relevant experience, or Master’s with 3+ years (QC raw material background).
- Experience with spectroscopic, chromatographic, and wet chemistry methods.
- Familiarity with global pharmacopeias and monograph testing.
- Ability to follow SOPs and comply with cGMPs; generate SOPs.
- Experience implementing compendial test methods and instrumental analytics; strong technical writing.
- Experience in a pharmaceutical testing environment.
- Proficient in Microsoft Office (Word, Excel, PowerPoint).
- Knowledge of GLPs/GMPs, laboratory techniques/safety, and regulatory/industry guidance.
- Perform methods and procedures for inspecting, testing, and evaluating raw materials.
- Support program improvements including SOPs, new test methods, improved specifications, raw material qualification program, and alignment of raw material procurement with other sites.
- Streamline and improve compliance and efficiency in Quality Control programs; develop, implement, and maintain QC quality control systems and activities.
- Conduct out-of-specification (OOS) and failure investigations; recommend and implement corrective actions.
- Responsible for tracking and completion of quality investigations and compliance records for the QC department.
Essential Functions
- Support implementation of the raw material program at EMOB.
- Lead change for revision of existing tests and development of new assays in accordance with internal processes, compendial requirements, and GxP.
- Assess compendial changes; revise assays and identify need for new assay development.
- Perform daily routine sampling and testing of raw materials; perform lab cleaning (weekly/monthly).
- Use analytical/compendial methods: FTIR, pH measurement, refractometry, density/specific gravity (density meter), UV-VIS, distillation, titrations, AKTA, HPLC, GC.
- Enter sample and result data into LIMS Lab Vantage; perform data analysis and prepare results for review.
- Ship samples; monitor contract lab test results; coordinate with third parties and manufacturers to implement testing methodologies.
- Prepare specifications, SOPs, method verification protocols/reports; support equipment qualification, calibration, preventive maintenance.
- Lead Period Review, OOS, deviations, Change Control, and CAPAs; design/implement corrective action plans.
Qualifications / Requirements
- Bachelor’s in Chemistry or related field with 5+ years relevant experience, or Master’s with 3+ years (QC raw material background).
- Experience with spectroscopic, chromatographic, and wet chemistry methods.
- Familiarity with global pharmacopeias and monograph testing.
- Ability to follow SOPs and comply with cGMPs; generate SOPs.
- Experience implementing compendial test methods and instrumental analytics; strong technical writing.
- Experience in a pharmaceutical testing environment.
- Proficient in Microsoft Office (Word, Excel, PowerPoint).
- Knowledge of GLPs/GMPs, laboratory techniques/safety, and regulatory/industry guidance.