Quality Assurance Specialist II

Quality Assurance Specialist II in Springfield, MO

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

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!

The Quality Assurance Specialist II serves as a quality partner to manufacturing and laboratory operations, providing on‑floor oversight, data and documentation review, and proactive compliance support. This role identifies and addresses compliance risks, supports resolution of quality events, and helps ensure manufacturing and laboratory activities are performed in accordance with cGMPs, data integrity principles, and Curia procedures.

The QA Specialist II supports Curia’s Quality Management System through analytical data review, quality event management, audit support, and maintenance of quality systems and records while collaborating across functions to promote consistent, compliant execution.

• Provide on‑floor QA oversight to manufacturing operations, proactively identifying compliance risks and supporting day‑to‑day quality activities.

• Represent Quality Assurance when issues require immediate corrective action, ensuring actions are appropriate, compliant, and accurately documented.

• Support the initiation, documentation, investigation, and resolution of deviations and other quality events.

• Monitor operations for compliance with approved procedures, batch records, protocols, cGMP requirements, and Good Documentation Practices.

• Partner with Manufacturing, Quality Control, Technical Services, and other functions to resolve quality issues, support real‑time compliance, and elevate significant concerns to Quality Management.

• Provide guidance to personnel regarding cGMP requirements, site procedures, documentation practices, and quality expectations.

  Data and Documentation Review

• Review Quality Control analytical testing and associated data for completeness, accuracy, traceability, and compliance with approved methods, specifications, SOPs, cGMP requirements, and data integrity principles.

• Review analytical documentation, including chromatography and other laboratory‑generated data, as applicable, to verify appropriate execution, calculations, results, and adherence to established procedures and specifications.

• Identify discrepancies, atypical results, documentation errors, and potential data integrity concerns and partner with laboratory personnel and Quality Management to ensure appropriate evaluation and resolution.

• Review manufacturing and quality documentation, including batch records, protocols, controlled forms, and other cGMP records, for completeness and compliance.

• Apply sound judgment and critical thinking when reviewing data and documentation and ensure corrections or clarifications are completed in accordance with Good Documentation Practices.

  Quality Systems

• Author, review, and/or approve Quality Management System documentation, including SOPs, deviations, change controls, CAPAs, controlled forms, and other quality records within assigned authority.

• Support investigations through documentation and data review, information gathering, and evaluation of immediate actions.

• Maintain Quality databases,…