Quality Assurance Specialist III

About the Role

The Quality Assurance Specialist III serves as an embedded quality partner to manufacturing 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 and audit participation to deviation management and client communication. 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.

Responsibilities

• Floor Presence and Compliance
  • Provide on-the-floor QA oversight to manufacturing 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, 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 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 and Curia's quality system to ensure real-time compliance.
• 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, 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
  • Perform work in alignment with cGMP requirements and Curia's standards to ensure facilities support the safe and reliable manufacture of products for 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.

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

Preferred Qualifications

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

Other Requirements

• 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

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

Education, experience, location and tenure may be considered along with internal equity when job offers are extended.