Quality Control Analyst II

Position overview

Testing and laboratory operations

• Tests incoming, in-process, final-product, and stability samples using balances, pipettes, pH meters, UV/Visible spectrophotometers, TOC analyzers, and other equipment.
• Performs chromatography, including HPLC, GC, and UPLC, alongside wet chemistry, analytical assays, and raw-material testing or sampling.
• Backs up QC instrument maintenance and calibration and performs general laboratory equipment maintenance.
• Maintains laboratory housekeeping and prepares the laboratory for audits.

Methods, investigations, and support

• Performs or assists with QC method qualifications, transfers, validations, and method development.
• Conducts out-of-specification and laboratory deviation investigations and assists QC management with related CAPA investigations.
• Provides technical support to shift analysts and performs cleaning validation studies.
• Assists with evaluation of new equipment and processes and reviews QC data for management summaries.

Sample coordination

• Backs up sample receipt for internal and external testing, including login, processing, shipment, tracking, test-result distribution, and closure.

Education and experience

• Required: Bachelor's degree in Chemistry or a related field.
• Required: 3–5 years of pharmaceutical-industry experience or equivalent education and experience.
• Preferred: Experience in a cGMP or GLP pharmaceutical-industry environment.

Knowledge and abilities

• Requires strong verbal and written communication, time management, organization, and independent project-management skills.
• Requires ability to work under pressure with limited supervision, interpret technical instructions and regulations, and prepare reports and procedures.
• Requires advanced mathematical ability, including statistical analysis, sampling theory, and assessment of test reliability and validity.
• Requires proficiency with Microsoft Office Suite and instrument manufacturer-based systems.
• Requires knowledge of FDA GMPs and applicable 21 CFR regulations; ISO 9001 and 13485 knowledge is a plus.

Pay range

• The stated pay range is $67,000–$80,000; no compensation cadence is specified.

Benefits

• Benefits include benefit options, paid training, vacation and holidays, education reimbursement, a 401(k) matching program, and a learning platform.

About Curia

Application

• Applicants must apply online.