Quality Assurance Specialist III

Curia • Springfield, MO

5d

About The Position

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. The role identifies and mitigates compliance risks before and during production, drives adherence to cGMPs and internal procedures, and ensures deviations are addressed with appropriate, timely, and thoroughly documented corrective actions.

The position maintains and supports Curia’s Quality Management System through document authorship, analytical data review, audit participation, deviation management, and client communication. At level III, the specialist applies strong knowledge of cGMP requirements, data integrity principles, and analytical laboratory practices, including chromatography, to assess records and data for accuracy, completeness, compliance, and scientific soundness. The role is self-directed and collaborative, helping keep quality systems inspection-ready and client timelines on track.

The work includes a standard office environment and frequent entry into a pharmaceutical manufacturing production area. The production environment may involve moving mechanical parts, fumes or airborne particles, extreme heat, wet or humid conditions, low levels of toxic or caustic chemicals, and outdoor weather conditions. Noise is typically moderate. Curia will review reasonable accommodation requests to enable individuals with disabilities to perform the role’s essential functions.

Requirements

• Bachelor’s degree in Life Sciences or a related field; alternate fields of study may be considered in combination with significant industry experience.
• For level III, 6–8 years of QA, QC, analytical laboratory, or related quality experience in pharmaceutical, biotechnology, medical device, or another cGMP FDA-regulated industry.
• Experience reviewing analytical laboratory data in 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, and 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.

Nice To Haves

• 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 other analytical data for cGMP and data integrity compliance.

Responsibilities

• Provide on-the-floor QA oversight to manufacturing and laboratory operations, identify compliance risks, and coordinate daily quality activities.
• Represent Quality Assurance when issues require immediate corrective action and ensure actions are appropriate and documented for traceability and investigation support.
• Assist with 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.
• Participate in quality improvement initiatives, including their development and implementation.
• 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 quality documentation and systems to maintain inspection readiness for domestic and international regulatory bodies, including ISO, FDA, QP, and 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.
• Perform or support QA review of analytical data and associated documentation for 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 chromatograms, calculations, audit trails, and supporting documentation as applicable.
• Evaluate analytical data and laboratory documentation for data integrity concerns, atypical results, documentation discrepancies, or other compliance risks, and ensure appropriate escalation and investigation.
• 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 in keeping client timelines on schedule, communicating proactively with customer contacts as needed.
• Report personnel performance observations to appropriate management, including areas for improvement and individuals exceeding expectations.
• Perform 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 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.

Benefits

• Generous benefit options, eligible from the first day of employment.
• Paid training, vacation, and holidays; vacation accrual begins on the first day of employment.
• Career advancement opportunities.
• Education reimbursement.
• 401(k) program with matching contributions.
• Learning platform.

What This Job Offers

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