Quality Assurance Specialist
2 weeks ago
**This is where you save and sustain lives**
At Baxter, we are deeply connected by our mission. No matter your role at Baxter, your work makes a positive impact on people around the world. You'll feel a sense of purpose throughout the organization, as we know our work improves outcomes for millions of patients.
Baxter's products and therapies are found in almost every hospital worldwide, in clinics and in the home. For over 85 years, we have pioneered significant medical innovations that transform healthcare.
Together, we create a place where we are happy, successful and inspire each other. This is where you can do your best work.
Join us at the intersection of saving and sustaining lives—where your purpose accelerates our mission.
The Role**: Night Shift Quality Assurance** **Specialist**
We are currently looking for a dedicated **Night Shift Quality Assurance** **Specialist **to join our Compounding & QA Team in our **Toongabbie, NSW** site for a **12-month FTC** position. Reporting to **Quality Operations Manager,** you will provide oversight for night shift operations and ensure that the Compounding site(s) jurisdiction produces safe, effective, quality compounded products and operates in compliance with applicable Regulatory and Corporate GMP and Quality Management System requirements.
**Shift Timing**: This role is Monday to Friday, 17:00 pm to 01:00 am (Nightshift)
**Duties & Responsibilities**:
- Provide Quality oversight of operations during night shift operations.
- Manage GMP and Quality risk on behalf of the site during night shift operations, ensuring compliance to QMS and ensure risks are acted on and escalated in a timely, appropriate and compliant manner.
- Contribute to maintaining the site sterility assurance programme, including environmental monitoring, media fills, Real Time Risk Assessments, process validations and micro plate reconciliation.
- Management of extended hours testing and additional media fills
- Manage investigation of non-conformance events which occur during night shift operations including PQI, NCRs and Complaints.
- In conjunction with site manager, assist with preparation for internal, corporate and regulatory inspections.
- Collect and analyse key quality indicators ensure any adverse trends and/or continuous improvement opportunities are identified, actioned and escalated if appropriate
- Assist with Quality System implementation and maintenance
**Essential Skills and Qualifications**
- Tertiary Science Graduate (preferably Chemistry, Microbiology, Life Sciences), Pharmacist or equivalent
- Minimum of 3 years experience in a GMP or similarly regulated manufacturing environment.
- Knowledge of sterile/aseptic manufacture (specifically compounding) is an advantage
- Experience in implementing and maintaining quality systems in a regulated environment is an advantage
**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.
We are proud to be recognized 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 an equal opportunity employer and makes employment decisions without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status, or any other status protected by law._
**Reasonable Accommodations**
**Recruitment Fraud Notice**
Baxter 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 Recruitment Fraud Notice.
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