Quality Assurance Specialist I

Curia • Springfield, MO

1d • Onsite

About The Position

The Quality Assurance Specialist I is a key contributor in upholding product quality, patient safety, and customer trust. This role maintains quality systems and provides a strong on-the-floor presence within manufacturing, ensuring operations are performed in alignment with regulatory requirements, internal standards, and Curia’s commitment to doing work the right way.

With a focus on Curiosity, Urgency, Respect, Integrity, and Accountability, the Quality Assurance Specialist I proactively identifies compliance risks before and during manufacturing activities, helping prevent deviations whenever possible. When issues arise, this role acts with urgency and ownership to support immediate corrective actions, ensuring they are clearly documented, traceable, and aligned with cGMP and internal procedures.

Working primarily in cGMP production environments, the Specialist partners closely with manufacturing teams to reinforce adherence to the quality system, initiate and support deviation processes, and contribute to timely, effective resolution. Through consistent presence, attention to detail, and collaboration, this role helps build a culture where quality and compliance are embedded in every step of the process.

Requirements

• Bachelor’s degree in Life Science or related field
• Minimum 0-3 years’ experience in a cGMP and FDA-regulated industry

Nice To Haves

• Excellent verbal and written communication skills
• Focused self-starter with attention to detail
• Team-oriented, but able to work independently and proactively
• Ability to multi-task
• Strong problem solving and organizational skills
• Strong critical thinking skills, including familiarity with root-cause analysis

Responsibilities

• Provide on-the-floor QA presence as needed to ensure manufacturing activities are performed in alignment with cGMP requirements, site procedures, and regulatory expectations
• Monitor and reinforce adherence to SOPs, batch records, protocols, change controls, and other controlled documents
• Identify, escalate, and help address quality risks in real time, partnering with teams to implement compliant solutions
• Represent Quality Assurance in situations requiring immediate corrective action, ensuring actions taken are appropriate and properly documented
• Review batch records and quality documentation to ensure accuracy, completeness, and compliance with ALCOA++ and site standards
• Maintain and support quality documentation systems, including archival, scanning, and controlled document management
• Author, review, and/or support approval of Quality Management System documents such as SOPs, deviations, CAPAs, and change controls
• Initiate, track, and support the resolution of deviations, investigations, change controls, and CAPAs
• Assist with root cause investigations and ensure documentation supports clear, traceable outcomes
• Contribute to the development and maintenance of quality metrics for management review
• Solicit cross-functional feedback to identify opportunities for operational and quality improvements
• Perform and/or support internal audits, walkthroughs, and external inspections
• Conduct QA visual inspection activities as required
• Help ensure the site remains inspection-ready through consistent application of quality standards
• Provide guidance and support to team members on cGMP requirements, SOPs, and documentation practices
• Maintain current training in cGMP and applicable regulatory requirements
• Collaborate with manufacturing and cross-functional teams to promote a culture of quality, accountability, and continuous learning
• Continue building knowledge of regulatory expectations and quality systems in a fast-paced environment

Benefits

• 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

What This Job Offers

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