Quality Control Analyst II
Curia
Summary
The Quality Control Analyst II is responsible for performing routine and non-routine analytical chemistry assays of raw materials, in-process samples, finished APIs, and stability samples. This role also participates in special projects, method development/transfers and cleaning study qualifications.
Job description
Responsibilities
- Perform analytical testing for incoming, in-process and final products, and stability samples using equipment such as balances, pipettes, pH meter, UV/Visible spectrophotometer, Total Organic Carbon analyzer, etc.
- Perform chromatography (HPLC/GC, UPLC) with minimal qualification and training, wet chemistry assays, analytical chemistry assays, HPLC, GC, IR, UV, etc. and raw material testing and/or sampling
- Back up for QC analytical instrument maintenance and calibration
- Perform QC general laboratory equipment maintenance, laboratory housekeeping and preparation of the laboratory for audits
- Perform or assist with QC method qualifications, transfers and validations
- Perform QC method development
- Perform cleaning validation studies
- Assist with the evaluation of new equipment and processes
- Assist in the review of QC data and provide summaries to management as needed
- Assist QC Management, as needed, in the completion of OOS, deviations, and CAPAs investigations for QC
- Backup for QC analytical sample receipt for internal testing, outside laboratory testing, login, processing, shipment, tracking, distribution of test results, and closure
Qualifications
Bachelor’s degree in Chemistry or a relevant field and 3 years of related work experience, OR Master’s degree in Chemistry or a relevant field and 1 year of related work experience
Preferred Experience
- Chromatography: SEC-HPLC, UPLC, and related methods for purity and impurity analysis
- Electrophoretic techniques: CE-SDS, cIEF (e.g., Maurice/PA800 platforms) for protein characterization and charge/size variants
- Ligand-binding assays: ELISA (e.g., potency, HCP, residual Protein A) and/or Octet/BLI for binding and functional characterization
- Molecular methods: qPCR-based assays (e.g., residual DNA, mycoplasma)
- Biochemical assays: UV/Vis, mBCA, pH, conductivity, osmolality, and general wet chemistry techniques
- Product quality assessments: visual appearance, subvisible particles, and integrity testing
Other Qualifications
- Must pass a background check
- Must pass a drug screen
- May be required to pass Occupational Health Screening
Requirements
- Bachelor’s degree in Chemistry or a relevant field and 3 years of related work experience, OR Master’s degree in Chemistry or a relevant field and 1 year of related work experience
- Perform analytical testing for incoming, in-process and final products, and stability samples using equipment such as balances, pipettes, pH meter, UV/Visible spectrophotometer, Total Organic Carbon analyzer, etc.
- Perform chromatography (HPLC/GC, UPLC) with minimal qualification and training, wet chemistry assays, analytical chemistry assays, HPLC, GC, IR, UV, etc. and raw material testing and/or sampling
- Back up for QC analytical instrument maintenance and calibration
- Perform QC general laboratory equipment maintenance, laboratory housekeeping and preparation of the laboratory for audits
- Perform or assist with QC method qualifications, transfers and validations
- Perform QC method development
- Perform cleaning validation studies
- Assist with the evaluation of new equipment and processes
- Assist in the review of QC data and provide summaries to management as needed
- Assist QC Management, as needed, in the completion of OOS, deviations, and CAPAs investigations for QC
- Backup for QC analytical sample receipt for internal testing, outside laboratory testing, login, processing, shipment, tracking, distribution of test results, and closure
- Must pass a background check
- Must pass a drug screen
- May be required to pass Occupational Health Screening
Benefits
- Generous benefit options
- Paid training
- Vacation
- Holidays
- Career advancement opportunities
- Education reimbursement
- 401(k) Matching
- Learning platform
Company overview
Curia is a leading global Contract Development and Manufacturing Organization (CDMO) with over 30 years of experience in the pharmaceutical industry. Headquartered in Albany, New York, the company operates an integrated network of 25 global sites across North America, Europe, and Asia, employing approximately 3,500 professionals. Curia provides comprehensive end-to-end solutions spanning drug discovery, development, and manufacturing services for both small molecules and biologics. Their expertise covers active pharmaceutical ingredient (API) manufacturing, sterile drug product development, analytical testing, and regulatory support. The company specializes in complex areas including high-potency compounds, controlled substances, sterile APIs, and mRNA manufacturing. With state-of-the-art GMP facilities and a strong focus on innovation, Curia partners with pharmaceutical and biotechnology companies to accelerate the development and commercialization of life-changing therapeutics, from early-stage discovery through commercial-scale production.