Senior Scientist, Quality Assurance

4 days ago

Brisbane, Queensland, Australia beBeePhysicist Full time $100,000 - $140,000
Job Title

Senior Quality Assurance Specialist, Physiochemistry & Raw Materials.

Reports to: Senior Quality Operations Manager.

Group / Division: Process Systems and Genealogy (PSG) / Downstream Development (DSD)

Career Band: 05

Job Family:Operations

Job Sub Family:Quality Control

Position Location: Brisbane, Australia

Job Description:

The role of the Quality Control Laboratory is to execute qualification/validation protocols, technical transfers as applicable and perform quality control tests. This laboratory provides high-quality testing services ensuring that our products meet regulatory requirements for safety, efficacy, and compliance with international quality standards.

Key Responsibilities:
  • Lead the day-to-day management of the Quality Control Physiochemistry and Raw Materials team including planning activities and resources, execution of analysis, reporting results, and key performance indicators.
  • Coach, train, and support other team members in achieving their goals.
  • Ensure compliance of facilities, raw materials, products, and systems with international quality requirements and customer specific requirements.
  • Timely and scientifically sound output of the Quality Control Physiochemistry Laboratory according to regulatory requirements and cGMP.
  • Coordinate Raw Material testing/release in accordance with relevant Pharmacopoeia.
  • Identify, investigate, and close non-conformances and out-of-specification/out-of-trend test results on time with high quality.
  • Responsible for lab equipment maintenance upgrades and improvements.
  • Lead and assist with process improvement projects.
Frequent Contacts:

All Internal Departments including Quality Assurance, Quality Control, and Operations.

Customers, Regulatory Agencies, Other Business Units within Thermo Fisher Scientific, Equipment/Contract Laboratory/Maintenance vendors, and contractors.

Minimum Requirements/Qualifications:

Qualifications and Experience:
- Bachelor of Science (Biotechnology, Chemistry, or closely related degree). Background in analytical theory and technical competency with laboratory analysis. Knowledgeable with cGMP and various laboratory analyses, efficient sample workflows, in-process controls, analytical testing, and equipment maintenance.- Ability to work on multiple projects simultaneously.- Strong team-working and collaborative skills.

Skills and Attributes:
  • Adaptability: Ability to adapt to daily business requirements.
  • Collaborating: Competency to work with all departments and colleagues of varied backgrounds.
  • Continuous Improvement: Drive process improvement initiatives.
Other Job Requirements:

Deliver best-in-class technical and scientific solutions to enhance product value. Build a culture of engagement, accountability, and shared commitment to excellence. Adhere to all Environmental Health and Safety policies and procedures, operate business responsibly, safely, and ethically. Work safely, only perform tasks if currently competent and/or authorized, participate in EH&S activities such as GEMBA walks, inspections, and risk assessments.

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