Address Job Description
At Thermo Fisher Scientific, each one of our 100,000 extraordinary minds has a unique story to tell. Join us and contribute to our mission; enabling our customers to make the world healthier, cleaner and safer.
When you're part of the team at Thermo Fisher Scientific, you'll do important work. Surrounded by collaborative colleagues, you'll have the support and opportunities that only a global leader can give you. Our respected, growing organization has an outstanding strategy for the near term and beyond. Take your place on our strong team, and help us make significant contributions to the world.
Job Title: Quality Specialist
Reports to: Quality Assurance Manager
Position Location: On site - Scoresby, Victoria
The Quality Specialist is responsible for supporting Thermo Fisher Scientific ANZ Quality Management Systems across its 4 sites in Australia and New Zealand (Scoresby VIC, Washington WA, Seventeen Mile Rocks QLD, and Albany NZ). The Quality Specialist II will play an integral role in supporting our mission to enable our customers to make the world healthier, cleaner and safer.
Key Responsibilities:
Contribute to our customers' satisfaction by helping support a quality management system (QMS) based on the requirements of our certifications such as ISO 9001:2015 and 17025:2017 as well as other commitments made by leading or supporting the following:
Document Control
- Review submitted documents to ensure compliance with the current requirements.
- Coordinate document change and review process.
- Manage document release process.
Customer Complaints
- Oversee the customer complaint process ensuring an effective and efficient approach and continuously improving where appropriate. Also the implementation of the process including training, support and reporting.
Quality Agreements
- Maintain quality agreements with service providers, suppliers and customers as required by any certification, corporate requirement or customer agreement.
- Coordinate the circulation and review of draft quality agreements to ensure we're able to honour the commitments made.
Release of Product
- Oversee the hold process for finished goods.
Customer Vendor Assurance
- Assist with the completion of customer and vendor quality surveys.
Contribute to the functioning of the quality system by, when required, supporting processes such as:
- CAPA
- Deviation Management
- Training
- Change Management
- Supplier Management
- Internal Audit
- Reporting
- Performance Review/Trending
Minimum Requirements/Qualifications:
- A Bachelor's Degree (or equivalent) in a scientific discipline
- Strong knowledge of, and experience with, quality systems, specifically ISO 9001:2015.
- Good communication skills (written and oral)
- Experience in: Root Cause Assessment, Processes Mapping and Document Control.
- Experience working with groups of people to solve problems.
- Internal auditor qualifications would be highly regarded
- Knowledge of, and experience with ISO 17025:2017 is desirable
Competencies and Traits
- Decision Quality - Making good and timely decisions that benefit the long term performance of the business.
- Resourcefulness - Securing and deploying resources appropriately and effectively
- Ensures Accountability - Being accountable and able to hold others accountable to meet commitments
- Collaborates - Building partnerships and working collaboratively with others to meet shared objectives
- Optimises Work Processes - Finding highly effective and efficient approaches to get things done, with a strong focus on continuous improvement
- Communicates Effectively - Developing and delivering multi-mode communications that convey a clear understanding of the needs of different audiences
- Software Competency - Experience with digital systems, specifically SharePoint, Power BI.
Other Job Requirements:
- Adhere to OHS policies and procedures and ensure a safe and healthy workplace environment
- Adhere to the Chain of Responsibility obligations under the Australian Heavy Vehicle National Law
Thermo Fisher Scientific is an EEO/Affirmative Action Employer and does not discriminate on the basis of race, colour, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability or any other legally protected status.
Thermo Fisher Scientific is an EEO/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability or any other legally protected status.
