Quality Control Analyst II

Curia • Hopkinton, MA

1d • $76,000 - $95,200

About The Position

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.

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
• And more!

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level