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About the Role

The QC Scientist – Physiochemistry & Raw Material supports quality control activities associated with the testing and release of raw materials products at the Brisbane site. The role provides scientific and technical expertise across physiochemistry and raw material quality control activities, ensuring testing and associated release activities are performed in accordance with approved procedures, specifications and GMP requirements. The position works collaboratively across Supply Chain, Quality and Manufacturing, supporting Quality System activities, continuous improvement and the consistent application of GMP and Quality Control principles across site operations.

Responsibilities

Perform and provide technical oversight of raw material sampling, testing and release activities in accordance with approved procedures and GMP requirements.
Apply strong technical knowledge of physiochemistry testing techniques and associated laboratory instrumentation, including pH, conductivity, osmolality, total organic carbon (TOC), and other relevant analytical equipment.
Execute, assess and interpret analytical testing against approved procedure, specifications and methods, applying appropriate scientific rationale to the evaluation of results.
Execute and support testing activities in accordance with approved test records, customer requirements and applicable Quality System requirements.
Perform peer and technical review of analytical data and test records to ensure accuracy, completeness, data integrity (ALCOA+) and compliance with approved procedures.
Assist QC Physiochemistry Team Leader in review/approval of test records, where relevant.
Identify and report non-conformances and OOS/UR results directly to Team Leader, Supervisor and Manager.
Understanding of the Quality Control practices and principles across the full spectrum of site manufacturing services.
Support in the practical application of various risk assessment tools (i.e. failure mode effect analysis, fishbone diagrams, hazard and operability studies) and ability to directly develop, participate, and advise others on the appropriate and efficient application of these processes.
Take a leading role within the team in the practical application of the Quality System, Change Control, Deviations, CAPA, OOS and OOT, Document Management, related to the Quality Control Department.
Assist with site PPI projects.
Perform any other legitimate duties as directed by the Team Leader, QC Supervisor or QC Operations Manager.

Requirements

At least 2 years’ experience in the biopharmaceutical and/or pharmaceutical industry aligned to Analytical and Quality Control fields.
Strong background in analytical theory and technical competency with laboratory analysis.
Familiarity with principles of Aseptic techniques.
Alignment with Thermo Fisher Scientific 4i Values: Integrity, Intensity, Innovation, and Involvement.
Ability to work in a highly dynamic, frequently changing environment with a wide variety of people and perspectives.
Proven record of ability to work as a team member and independently as required.
Ability to effectively communicate in multiple modalities (e.g. electronic, written, verbal, etc.).
Ability to work on multiple projects simultaneously and demonstrate initiative to complete tasks according to company milestones / goal tree.
Strong team working and collaborative skills.

Skills

Physiochemistry testing techniques
Laboratory instrumentation
pH testing
Conductivity testing
Osmolality testing
Total organic carbon (TOC) testing
Analytical equipment
Analytical data review
Test record review
Quality System activities
Continuous improvement
GMP principles
Quality Control principles
Risk assessment tools
Failure mode effect analysis
Fishbone diagrams
Hazard and operability studies
Quality System
Change Control
Deviations
CAPA
OOS
OOT
Document Management
PPI projects
Microsoft applications
Excel
Word
Outlook
PowerPoint

Location

Brisbane

Work Type

Permanent
Full-time
Standard (Mon-Fri)

Experience Level

At least 2 years’ experience

Education Level

Bachelor of Science (Biotechnology, Chemistry, or closely related degree)
Post Graduate qualifications – beneficial

Benefits

Comprehensive benefits
Wellness programs
Employee Assistance Program
Flexible arrangements
Generous leave policies
Option to purchase additional leave
Paid birthday leave
Company paid parental leave
Paid volunteer time
Access to online courses via Thermo Fisher Scientific University Plus
LinkedIn learning
Workshops
Mentorship programs

About the Company

As part of the Thermo Fisher Scientific team, you’ll discover meaningful work that makes a positive impact on a global scale.
Our Mission is to enable our customers to make the world healthier, cleaner and safer.
As one team of 125,000+ colleagues, we share a common set of values - Integrity, Intensity, Innovation and Involvement - working together to accelerate research, solve complex scientific challenges, drive technological innovation and support patients in need.
#StartYourStory at Thermo Fisher Scientific, where diverse experiences, backgrounds and perspectives are valued.

Equal Opportunity

Thermo Fisher Scientific Australia WGEA Employer of Choice for Gender Equality
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.