Quality Control Analyst II

Curia

1d • $76,000 - $95,200

About The Position

Quality Control Analyst II in Hopkinton, MA Build your future at Curia, where our work has the power to save lives. The Quality Control Analyst II is responsible for performing routine and non-routine analytical chemistry assays of raw materials, in-process samples, and stability samples. This role also participates in special projects, method development/transfers and cleaning study qualifications. Curia is a global contract development and manufacturing organization (CDMO) with over 30 years of experience partnering with pharmaceutical and biotech companies to provide life-saving treatments to patients. At Curia, we are on a mission to advance our customers’ therapies from curiosity to cure and ultimately to improve patients’ lives. We proudly offer Generous benefit options (eligible first day of employment) Paid training, vacation and holidays (vacation accrual begins on first day of employment) Career advancement opportunities Education reimbursement 401K program with matching contributions Learning platform And more!

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
• Must pass a background check
• Must pass a drug screen
• May be required to pass Occupational Health Screening

Nice To Haves

• Experience in any of the following techniques: 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

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

Benefits

• Generous benefit options (eligible first day of employment)
• Paid training, vacation and holidays (vacation accrual begins on first day of employment)
• Career advancement opportunities
• Education reimbursement
• 401K program with matching contributions
• Learning platform

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Number of Employees: 501-1,000 employees