Quality Assurance Specialist III
On-siteSpringfield, Missouri, United States
Job Summary
Provide on-the-floor QA oversight to manufacturing operations, proactively identifying compliance risks and coordinating day-to-day quality activities. Represent Curia Quality Assurance when issues require immediate corrective action, ensuring actions are appropriate, timely, and thoroughly documented. Author, revise, and approve Quality Management System documents including SOPs, CAPAs, and validation documentation while supporting inspection readiness for FDA and international regulatory bodies. Participate in internal and external audit programs, from planning and conducting audits to managing client communications regarding manufacturing and testing issues. Track and follow up on deviations, change controls, and investigations to ensure timely closure and assist in quality improvement initiatives. Perform all documentation in compliance with ALCOA++ principles and cGMP requirements, maintaining current training and escalating concerns with proposed solutions.
Required Qualifications
- Bachelor's degree in Life Sciences or a related field; alternate fields of study may be considered in combination with significant industry experience
- Minimum 6–8 years of QA experience in pharmaceutical, biotechnology, medical device, or a cGMP FDA-regulated industry
- 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
- Must pass a background check
- Must pass a drug screen
- May be required to pass Occupational Health Screening
- May be required to obtain and maintain gowning certification
- May be required to obtain and maintain media qualification
Desired Qualifications
- Experience working with third-party contract manufacturing in the pharmaceutical industry
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