QA Specialist

About the role

The Change Control Plant QA Specialist is a member of the Quality unit responsible for overseeing change control and documentation activities, ensuring that changes to processes, products, or systems are properly reviewed and approved to maintain cGMP control of validated systems. This role also supports daily technical activities for Documentation Technicians and may review and approve SOPs, validation documents, and facilities/utility/equipment related procedures.

Responsibilities

• Administer the local change control system, records management system, and/or documentation system.
• Ensure corporate or site changes affecting Austin processes are reviewed for impact and tracked to completion.
• Maintain consistency and compliance of changes with local, corporate, and global regulatory requirements (CFR, Health Canada, PIC/s, etc.).
• Evaluate process and procedure changes as necessary.
• Drive continuous improvement of departmental processes.
• Review and approve validation documents.
• Facilitate the Change Control Review Board (CCRB) on a specified frequency to discuss and decide on change control content, deliverables, and issues.
• Review and approve facilities, utilities, and equipment related SOPs.
• Provide daily technical support for change control and document control activities of Documentation Technicians.
• Manage communications through discussion and compromise to reach agreement.
• Investigate exceptions related to the documentation center or change control processes, determine root cause, and recommend corrective actions.
• Write or assist with the writing of Standard Operating Procedures.
• Perform other related duties as assigned or required.

Knowledge, Skills & Qualifications

• High level of attention to detail with ability to prioritize and manage heavy workloads in a dynamic environment.
• Thorough knowledge and understanding of cGMPs, FDA and/or pharmaceutical industry guidelines.
• Strong organizational, presentation, project management, and meeting facilitation skills.

Education and Experience

• Bachelor’s Degree required; Science or Engineering preferred.
• 3–5 years of Quality experience in a regulated environment (FDA‑regulated environment preferred).

Minimum Qualifications

• Must be at least 18 years of age.

Travel Requirements

Typically requires travel less than 5% of the time.

Physical Requirements

• Office environment.
• Occasional lifting up to 25 lb.

About Us

We manufacture critical IV solutions that providers rely on to deliver consistent, reliable care. Each product we make helps ensure patients receive the therapies they need without disruption. Working here means being part of a team dedicated to reliability and innovation, directly strengthening the healthcare supply chain and impacting patients nationwide. We offer opportunities for growth, collaboration, and meaningful contributions in pursuit of a mission that truly matters.