Change Control QA Specialist - GMP & Documentation

Socket.dev; Austin (TX); On-site; USD 85,000 - 120,000; Full time

Job summary

Otsuka ICU Medical in Austin, TX seeks a QA professional to oversee change control and document control activities within the Quality unit. You will review and approve SOPs, validate documentation, and ensure cGMP compliance across regulatory requirements.

The role supports daily technical activities, facilitates CCRB meetings, and drives continuous improvement in change control processes. Bachelor's degree and 3–5 years in a regulated environment are required.

Qualifications

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

Responsibilities

• Administers the local change control system, records management system, and/or documentation system.
• Ensures corporate or other site changes relating to Austin processes are reviewed for impact and that Austin commitments are tracked to completion.
• Ensures consistency and compliance of changes with local, corporate and global regulatory requirements (CFR, Health Canada, PIC/s, etc.).
• Evaluate process/procedure changes; drive continuous improvement of departmental processes.
• May review and approve Validation documents.
• May facilitate the Change Control Review Board (CCRB) to discuss content and issues.
• Review and approve facilities, utilities and equipment SOPs.
• Provide daily technical support for change control and document control activities.
• Communicate to reach agreement through discussion and compromise.
• Investigate exceptions to determine root cause and corrective action.
• Write or assist with Standard Operating Procedures.
• Perform other related duties as assigned.

Skills

Attention to detail

cGMP knowledge

Organizational skills

Presentation skills

Project management

Meeting facilitation

Education

Bachelor's degree in science or engineering

Job description

Otsuka ICU Medical in Austin, TX seeks a QA professional to oversee change control and document control activities within the Quality unit. You will review and approve SOPs, validate documentation, and ensure cGMP compliance across regulatory requirements.

The role supports daily technical activities, facilitates CCRB meetings, and drives continuous improvement in change control processes. Bachelor's degree and 3–5 years in a regulated environment are required.