QA Specialist

ICU Medical•Austin, TX

4d•Onsite

About The Position

The QA Specialist position involves overseeing various aspects of change control and documentation, including change control administration, records management, document control, and local/corporate change control. As a member of the Quality unit, this individual is responsible for ensuring that changes to processes, products, or systems are properly reviewed and approved to maintain cGMP control of validated systems. The role may also include reviewing and approving SOPs and documents related to site GMP facilities, equipment, utilities, and validation. Additionally, the QA Specialist may provide daily technical support for change control and document control activities to Documentation Technicians, facilitate the Change Control Review Board (CCRB), investigate documentation exceptions, and write or assist with Standard Operating Procedures.

Requirements

High level of attention to detail and the ability to prioritize and manage heavy workloads in a dynamic environment.
Thorough knowledge and understanding of cGMPs, FDA and/or pharmaceutical industry guidelines.
Good organizational, presentation, project management, and meeting facilitation skills.
Bachelor’s Degree is required: Science or Engineering preferred.
3-5 years of Quality experience in a regulated environment (FDA regulated environment preferred).
Must be at least 18 years of age.

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.
Review and approve Validation documents.
Facilitate 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.
Review and approval of facilities, utilities and equipment related SOPs.
Provide daily technical support for change control and document control activities of the Documentation Technicians.
Investigate exceptions related to the documentation center or various change control processes to determine root cause and appropriate corrective action(s).
Write or assist with the writing of Standard Operating Procedures.
Perform other related duties as assigned or required.