Senior Specialist, Quality Assurance

Vantive: A New Company Built On Our LegacyBaxter is on a journey to separate our ~$5B Kidney Care segment into a standalone company. Vantive* will build on our nearly 70-year legacy in acute therapies and home and in-center dialysis to provide best-in-class care to the people we serve. We believe Vantive will not only build our leadership in the kidney care space, it will also offer meaningful work to those who join us.At Vantive, you will become part of a community of people who are focused, courageous and don’t settle for the mediocre. Each of us are driven to help improve patients’ lives worldwide. Join us as we revolutionize kidney care and other vital organ support.*Completion of the proposed separation of Kidney Care from Baxter into a standalone company (to be named Vantive) remains subject to the satisfaction of customary conditions.The Role: Senior Specialist, Quality AssuranceAn exciting opportunity has arisen for a Senior QA Specialist to join our Quality team. Supporting the QARA Manager, you will support and influence the achievement of Quality Systems within Operations and Distribution to meet MOH GMP compliance, legal requirements, and the companies’ objectives. The successful candidate will have experience in all aspects of the Quality Management System (QMS).In this Full Time, Permanent position, you will support Baxter ANZ business with quality JDE support and monitor & process product holds for ANZ and will also perform Internal audits, supplier quality and documentation activities to support the businessKey Responsibilities:To ensure achievement of Quality Systems within Operations and Distribution, you will be responsible for:

• Perform Supplier Quality audits and qualification activities
• Documentation activities to support the business
• Internal Audits and Real Time Risk Assessments as per schedule
• Maintain the product hold database for ANZ to facilitate and/or implement product holds where product safety is questionable. This includes holds for local and imported finished goods, devices and raw materials based on Product Hold System or Field Action requirements, as well as release of Lots from Hold status in line with disposition
• Support the deviation programs associated with Quality issues in Distribution, provide technical guidance/guidelines to ensure investigation and corrective actions are completed on time as per GQP requirements
• Ensure changes to systems and processes (within areas of oversight) are documented and reviewed appropriately in order to ensure maintenance of compliance to Quality standards and GMP
• Assist in the monitoring for recurring trends and implementing continuous improvement to distribution processes,
• Provide technical assistance so that Baxter Quality objectives are met
• Lead all aspects of the coordination and submission of the monthly KPI metrics for Quality
• Review of conformance to specification and release of product for sale based on C of A for NZ
• Release of imported goods cold chain deliveries after the review of transport data
• Investigation of JDE system issues and errors interrupting QA business practices
• Complete JDE new product setup for QA parameters i.e. Status, Expiry Dating. Storage Conditions
• Supervise and coordinate rework requirements for imported product to ensure product is fit for sale within required timeframes
• Coordinate and participate in cross functional teams as necessary in order to progress projects
• Back up for Product Complaint related tasks as required
• Other duties, as may be required

Essential Skills and Qualifications

• Tertiary qualifications in an appropriate scientific discipline or applicable previous work experience

• Extensive background in the application of process improvement (improving systems/procedures)
• Experience in the application of process improvement (improving systems/procedures),
• Working knowledge of ISO9001 or ISO13485
• Experience in supplier qualification, JDE, and Warehousing and Distribution processes is preferred.

Desirable Skills:

• Excellent communication skills, including negotiation skills with ability to operate in a team environment
• Technical problem solving and decision-making skills for investigating issues and analysing trends,
• Excellent technical writing skills
• Organisational and planning skills, schedule tasks, keep accurate records; develop realistic action plans while being sensitive to time constraints and resource availability.

Why Baxter?At Baxter ANZ, we are focused on being a Best Place to Work where our people can be their authentic self, feel valued and respected. We are committed to a culture where all employees can collaborate and work together effectively.Relationships are a key component in how we operate in Baxter and we share the common traits of being reliable, ethical, caring, having empathy, actively listening to our colleagues as well as being open minded to new ideas and perspectives. Baxter is an organisation that makes inclusion and diversity a priority and that seeks to promote and improve gender equality in the workplace.We are proud to be recognised among the top 120 companies for the seventh consecutive year as an Employer of Choice for Gender Equality for delivering support structures for working families; stronger actions to address pay inequalities; and strategic recruitment and promotion practices that help to encourage the full participation of women at work. We are also pleased to be the winner of the 2021 & 2019 Women in MedTech Champion Company Award.Baxter is committed to supporting the needs for flexibility in the workplace. We do so through our flexible workplace policy which includes a minimum of 3 days a week onsite. This policy provides the benefits of connecting and collaborating in-person in support of our Mission.Situated in Western Sydney, and featuring and onsite cafeteria and café, gym, we offer a dynamic and future focused work environment offering workplace flexibility, development & career growth, volunteering leave, 12 weeks parental leave, income protection insurance and a strong value driven culture focused on diversity, equality, and inclusion.Baxter is an equal opportunity employer and makes employment decisions without regard to race, colour, religion, sex, sexual orientation, gender identity, national origin, veteran or disability status, or any other status protected by law. Baxter encourages applicants of all ages.Reasonable AccommodationsBaxter is committed to working with and providing reasonable accommodations to individuals with disabilities globally. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application or interview process, please click on the here and let us know the nature of your request along with your contact information.Recruitment Fraud NoticeBaxter has discovered incidents of employment scams, where fraudulent parties pose as Baxter employees, recruiters, or other agents, and engage with online job seekers in an attempt to steal personal and/or financial information. To learn how you can protect yourself, review our .