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Quality Assurance Specialist II/III 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/III serves as an embedded quality partner to manufacturing and laboratory operations, providing on-the-floor oversight and proactive compliance support. This role is focused on identifying and mitigating compliance risks before and during production execution, driving adherence to cGMPs and internal procedures, and ensuring that when deviations occur, corrective actions are appropriate, timely, and thoroughly documented.

This position maintains and supports Curia's Quality Management System across a broad range of activities, from document authorship, analytical data review, and audit participation to deviation management and client communication. The QA Specialist III applies strong knowledge of cGMP requirements, data integrity principles, and analytical laboratory practices, including chromatography, to evaluate records and data for accuracy, completeness, compliance, and scientific soundness. The QA Specialist III is a self-directed contributor who works collaboratively across departments to keep quality systems inspection-ready and client timelines on track.

Essential Responsibilities

Floor Presence and Compliance

- Provide on-the-floor QA oversight to manufacturing and laboratory operations, proactively identifying compliance risks and coordinating day-to-day quality activities as needed.

- Represent Curia Quality Assurance when issues require immediate corrective action, ensuring actions taken are appropriate and correctly documented to support traceability and investigation substantiation.

- Assist in or lead deviation and investigation processes, including initiation, immediate corrective action, root cause evaluation, and resolution.

- Track and follow up on Deviations, Change Controls, Investigations, and CAPAs to ensure timely closure.

- Actively participate in quality improvement initiatives, including development and implementation.

Quality Systems, Data Review, and Documentation

- Author, revise, review, and approve Quality Management System documents, including SOPs, CAPAs, Deviations, Change Controls, test methods, protocols, validation documentation, certificates of analysis, and equipment qualification documentation.

- Support compilation and maintenance of quality documentation and systems to ensure inspection readiness for domestic and international regulatory bodies (ISO, FDA, QP, EMEA).

- Develop, support, and maintain Quality System metrics for management review.

- Assist in training personnel in cGMPs, data integrity expectations, and Curia's quality system to ensure real-time compliance.

- Perform or support QA review of analytical data and associated documentation to verify accuracy, completeness, traceability, compliance with approved methods and procedures, and adherence to cGMP and data integrity requirements.

- Review analytical data generated through chromatography and other laboratory techniques, including associated chromatograms, calculations, audit trails, and supporting documentation, as applicable to the assigned area.

- Evaluate analytical data and laboratory documentation for potential data integrity concerns, atypical results, documentation discrepancies, or other compliance risks and ensure appropriate escalation and investigation.

Audits and Client Support

- Participate in and support internal and external audit programs, including planning, conducting audits, weekly walkthroughs, and preparing audit reports.

- Participate in regulatory, client, and external supplier qualification audits.

- With appropriate supervision, respond to or manage client communications regarding manufacturing, testing, analytical data, and documentation issues.

- Support QA team members and internal project teams to ensure client timelines are on schedule, communicating proactively with customer contacts as needed.

- Report personnel performance observations to appropriate management, noting both areas for improvement and individuals exceeding expectations.

Good Manufacturing & Documentation Practices

Quality is something we take pride in together. You'll perform your work in alignment with cGMP requirements and Curia's standards to ensure our facilities support the safe and reliable manufacture of products for our customers.

- Perform all documentation in compliance with ALCOA++ principles and site SOPs.

- Adhere to applicable cGMP documents including SOPs, batch records, protocols, change controls, and controlled forms.

- Keep all required cGMP training current and escalate quality concerns along with proposed solutions to the Quality department.

- Apply data integrity principles when reviewing electronic and paper records, including source data, metadata, audit trails, and associated documentation, as applicable.

Qualifications: Required

- Bachelor's degree in Life Sciences or a related field; alternate fields of study may be considered in combination with significant industry experience

- Minimum 3-6 years (level II) or 6-8 years (level III) of QA, QC, analytical laboratory, or related quality experience in pharmaceutical, biotechnology, medical device, or a cGMP FDA-regulated industry

- Experience reviewing analytical laboratory data within a cGMP environment, with demonstrated understanding of data integrity and good documentation practices.

- Working knowledge of chromatography principles and chromatographic data, such as HPLC and/or GC, with the ability to assess analytical records for compliance and data integrity.

- Strong familiarity with regulatory requirements including ICH Q7, Q9, Q10, and/or 21 CFR 210 and 211

- Excellent written and verbal communication skills, including the ability to present information clearly to management and peers

- Strong problem-solving and conflict resolution skills

- Ability to work independently and proactively while collaborating effectively across departments

- Detail-oriented, self-directed, and comfortable managing multiple priorities simultaneously

- Working knowledge of Microsoft Office or other relevant software

Preferred

- Experience working with third-party contract manufacturing in the pharmaceutical industry

- Experience with chromatography data systems

- Experience reviewing chromatographic data, audit trails, laboratory investigations, OOS/OOT results, or othe...

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