QA Specialist

Otsuka ICU Medical LLC; Austin (TX); On-site; USD 85,000 - 110,000; Full time

Job summary

Otsuka ICU Medical LLC is seeking a Change Control Plant QA Specialist to oversee local change control, records management, and documentation.

The role ensures cGMP control for validated systems and may review SOPs and validation documents.

Qualifications

• Bachelor's Degree in Science or Engineering required.
• 3-5 years of Quality experience in a regulated environment (FDA regulated environment preferred).
• Knowledge of change control processes and documentation is essential.

Responsibilities

• Administers the local change control system, records management system, and/or documentation system.
• Ensures changes are reviewed for impact and tracked to completion.
• Ensures compliance with local, corporate and global regulatory requirements (CFR, Health Canada, PIC/s, etc.).
• Drive continuous improvement of departmental processes.
• Review and approve Validation documents as needed.
• Facilitate the Change Control Review Board (CCRB) discussions and decisions.

Skills

Attention to detail

cGMPs knowledge

FDA guidelines

Organizational skills

Project management

Education

Bachelor's Degree in Science or Engineering

3-5 years of Quality experience in a regulated environment

Job description

Job Description Position Summary: Duties may include oversight of various aspects of change control and documentation, including but not limited to change control administration, records management, document control, local change control, and corporate change control. As a member of the Quality unit this individual is accountable for ensuring that changes made to processes, products or systems have been properly reviewed and approved to maintain proper cGMP control of validated systems. The Change Control Plant QA Specialist may also be responsible for the review and approval of SOPs and documents related to site GMP facilities, equipment and utilities as well as Validation documents. The Change Control Plant QA Specialist may also be responsible for daily technical support for change control and document control activities of the Documentation Technicians.

Essential Duties & 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.
• The Plant QA Specialist may be responsible for review and approval of facilities, utilities and equipment related SOPs.
• The Change Control Plant QA Specialist may be responsible for daily technical support for change control and document control activities of the Documentation Technicians.
• Come to agreement by managing communications through discussions and compromise.
• 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.

Knowledge, Skills & Qualifications:

• High level of attention to detail and the 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.

Education and Experience:

Bachelor's Degree is 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 and Work Environment:

Office environment. Occasional lifting up to 25 lbs.

About Us

Innovation, Impact, and Purpose. Find Your Future Here. We manufacture the critical IV solutions providers count on to deliver consistent, reliable care. Each product we make helps ensure patients receive the therapies they need without disruption. When you work here, you become part of something bigger-a team dedicated to reliability and innovation. No matter the role, your work directly strengthens the healthcare supply chain and impacts patients nationwide. We offer opportunities for growth, collaboration, and meaningful contributions, all in pursuit of a mission that truly matters. Join us and help shape the future of IV solutions.

EEO Statement:

Otsuka ICU Medical is committed to being an Equal Opportunity Employer. We ensure that all qualified applicants receive fair consideration for employment regardless of race, color, nationality or national origin, ethnicity, sex, gender, religion or belief, marital or civil partnership status, sexual orientation, pregnancy or maternity, age, disability, or protected veteran status. If you are an individual with a disability and need reasonable accommodation to participate in the employment selection process, please contact us at [e-mail]. We are committed to providing equal access and opportunities for all candidates.