Curia · 1 month ago
Quality Assurance Specialist III
2460 W Bennett Street, Springfield, MO, 65807, US
Full-time
Onsite
Senior Level
6+ years expCuria 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. The Quality Assurance Specialist III is responsible for maintaining Quality databases and providing on-the-floor QA presence and oversight to operations, ensuring compliance and managing corrective actions.
BiotechnologyHealth CareManufacturing
Responsibilities
Assist in developing and conducting training of personnel in full accordance with cGMPs and Curia’s quality system to ensure real-time compliance
Represent Curia Quality Assurance when managing issues that require immediate corrective action. Ensure such action taken is appropriate and correctly documented
Report back to appropriate management as to personnel performance, highlighting those areas and individuals in need of improvement as well as those exceeding expectations
Assist in Curia documentation compilation, systems and controls to ensure inspection-ready quality systems (ISO, FDA, QP, EMEA) for domestic and international inspections and registrations
Author, revise and/or review and approve Quality Management System documents, including, but not limited to, SOPs, CAPAs, Deviations, Un-executed/Executed quality records, Change Controls, test methods, protocols (stability, validation, etc.), executed validation documentation, certificates of analysis and/or equipment qualification documentation
Assist in internal and external audit programs and prepare reports as required. This may include planning audits, conducting audits and writing audit reports
Participate in and/or perform regulatory, client, and external supplier qualification audits as well as internal audits and weekly walkthroughs
Assist in or lead investigations
With supervision, may respond or manage responses to clients regarding manufacturing, testing, and/or documentation issues
Assist in tracking and follow-up on Deviations, Change Controls, Investigations, and CAPAs
Develop, support and/or maintain Quality System metrics for management review
Support QA specialists to ensure client timelines are on schedule and attainable. This includes communicating directly with internal project teams and customer contacts
Assist in resolving quality problems/concerns with various personnel
Provide on the floor support and oversight to operations, including coordinating and perform day to day activities as needed
Actively participate in quality improvement initiatives, including development and implementation
Qualification
Required
Bachelor's degree in Life Sciences or related field; alternate fields of study may be considered in combination with significant industry experience
Minimum 6-8 years' QA experience in pharmaceutical, biotechnology, medical device, and/or cGMP FDA-regulated industry
Excellent written and verbal presentation and communication skills
Strong facilitation skills
Strong problem-solving skills, with the ability to resolve conflict
Ability to effectively present information to management and/or peers
Comfortable working independently and proactively in combination with individuals in other departments across the organization
Focused self-starter with attention to detail and ability to multi-task
Strong familiarity with the regulatory requirements of ICH Q7, Q9, Q10, and/or 21CFR210 and 211
Working knowledge of Microsoft Office or other software as needed
Ability to work flexible schedule as needed to cover evenings, nights, weekends, and holidays
Preferred
Experience working with third-party contract manufacturing in the pharmaceutical industry
Gowning qualification (may be required)
Benefits
Generous benefit options
Paid training, vacation and holidays
Career advancement opportunities
Education reimbursement
401k program
And more!
Company
Curia
Curia is a biotechnology company that offers discovery biology, synthetic, medicinal chemistry, and small-scale manufacturing services.
1001-5000 employees
H1B Sponsorship
Curia has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (34)
2024 (17)
2023 (8)
Funding
Current Stage
Late StageTotal Funding
unknown2025-03-07Debt Financing
2017-08-31Private Equity
Leadership Team
Steve Lavezoli
Vice President, Biologics Division
Recent News
2025-10-31
thecanadianpressnews.ca
2025-10-29
Curia Global, Inc.
2025-10-27
Company data provided by crunchbase