Quality Control Analyst II

Curia Aalborg ApS; Hopkinton (MA); On-site; USD 80,000 - 85,000; Full time

Benefits offered by this job

Generous benefit options

Paid training & vacations

Career advancement

Education reimbursement

401K with matching

Learning platform

And more

Job summary

Curia in Hopkinton, MA is seeking a Quality Control Analyst II to perform routine and non-routine analytical chemistry assays on raw materials, in-process samples, finished APIs and stability materials. The role includes method development/transfers, validations and support for audits.

The position requires a chemistry background with 3 years (or a master’s with 1 year) of related experience, and hands-on experience with HPLC/UPLC, GC, UV/Vis, and related QC techniques.

Qualifications

• Bachelor’s degree in Chemistry or a relevant field with 3 years of related work experience, OR Master’s degree with 1 year of related work experience.
• Experience with analytical testing of raw materials, in-process samples, finished APIs and stability samples.

Responsibilities

• Perform analytical testing for incoming, in-process and final products and stability samples using balances, pipettes, pH meters, UV/Visible spectrophotometer and related equipment.
• Conduct chromatography (HPLC/GC, UPLC) and wet chemistry assays.
• Back up QC instrument maintenance and calibration.
• Maintain QC laboratory equipment and prepare for audits.
• Assist with QC method qualifications, transfers and validations.
• Assist in QC method development and cleaning validation studies.
• Assist evaluation of new equipment and processes and review QC data for management.

Skills

Analytical chemistry expertise

Quality control

Team collaboration

Education

Bachelor’s degree in Chemistry or a relevant field

Master’s degree in Chemistry or a relevant field

Tools

SEC-HPLC

UPLC

CE-SDS

cIEF

ELISA

Octet/BLI

qPCR

UV/Vis

pH meter

Job description

Job Description

Build your future at Curia, where our work has the power to save lives.

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, finished APIs, 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 lifesaving 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!

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 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

Other Qualifications

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

Pay Range

$80,000-$85,000/yr.

Education, experience, location and tenure may be considered along with internal equity when job offers are extended.

We do not accept unsolicited assistance from any headhunters or recruitment firms for any of our job openings. All resumes or profiles submitted by search firms to any employee at Curia, in any form without a valid, signed search agreement by an authorized signatory in place for the specific position, approved by Talent Acquisition, will be deemed the sole property of Curia. No fee will be paid in the event the candidate is hired by Curia because of the unsolicited referral.

Curia is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, or protected veteran status and will not be discriminated against on the basis of disability. Curia is an E-Verify employer.