Change Control QA Specialist - cGMP & Validation Expert

Otsuka ICU Medical; Austin (TX); On-site; USD 85,000 - 115,000; Full time

Job summary

Otsuka ICU Medical in Austin, TX seeks a Change Control Plant QA Specialist to oversee local change control, document control, and validation review activities. This role ensures cGMP compliance for processes, products, and systems and supports daily technical activities for Documentation Technicians.

Responsibilities include reviewing SOPs, facilitating CCRB meetings, and driving continuous improvement within the QA and change control functions in a regulated environment.

Qualifications

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

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 appropriately 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 as necessary.
• Drive continuous improvement of departmental processes.
• The Plant QA Specialist may be responsible for reviewing and approving Validation documents.
• The Plant QA Specialist may be responsible for facilitating the Change Control Review Board (CCRB) on a specified frequency to discuss and make decisions on change control content, deliverables and any issues that arise.

Skills

Attention to detail

cGMP knowledge

FDA/pharma guidelines

Documentation management

Project management

Meeting facilitation

Education

Bachelor's Degree in Science or Engineering

Job description

Otsuka ICU Medical in Austin, TX seeks a Change Control Plant QA Specialist to oversee local change control, document control, and validation review activities. This role ensures cGMP compliance for processes, products, and systems and supports daily technical activities for Documentation Technicians.

Responsibilities include reviewing SOPs, facilitating CCRB meetings, and driving continuous improvement within the QA and change control functions in a regulated environment.