QC Scientist - Physiochemistry & Raw Material

ThermoFisher Scientific; Perth; On-site; AUD 90,000 - 120,000; Full time

Benefits offered by this job

Health & Wellbeing

Flexibility

Extra Leave

Charitable Giving & Volunteering

Learning & Development

Job summary

Thermo Fisher Scientific Australia in Brisbane is seeking a QC Scientist – Physiochemistry & Raw Material to join our quality control team.

You will apply physiochemistry testing expertise, manage raw material release under GMP, and collaborate with Supply Chain, Quality and Manufacturing to ensure data integrity and compliant records.

Qualifications

• At least 2 years’ experience in biopharmaceutical/pharma analytical QC.
• Strong knowledge of analytical theory and laboratory testing.
• Familiarity with cGMP practices and QA principles.

Responsibilities

• Perform raw material sampling, testing and release per GMP.
• Provide technical oversight of physiochemistry testing and lab instrumentation.
• Review test records for accuracy, data integrity and compliance.

Skills

Analytical testing

GMP knowledge

Data integrity ALCOA+

Team collaboration

Excel

Education

BS Biotechnology/Chemistry

Postgraduate qualification beneficial

Tools

Smartsheets

Excel

Job description

Work Schedule

Standard (Mon-Fri)

Environmental Conditions

Able to lift 40 lbs. without assistance, Adherence to all Good Manufacturing Practices (GMP) Safety Standards, Cleanroom: no hair products, jewelry, makeup, nail polish, perfume, exposed piercings, facial hair etc... allowed, Cold Room/Freezers -22degreesF/-6degrees C, Laboratory Setting, No contact lens allowed; prescriptive glasses will be provided, Office, Some degree of PPE (Personal Protective Equipment) required (safety glasses, gowning, gloves, lab coat, ear plugs etc), Strong Odors (chemical, lubricants, biological products etc), Warehouse, Will work with hazardous/toxic materials

Job Description

As part of the Thermo Fisher Scientific team, you’ll discover meaningful work that makes a positive impact on a global scale. Join our colleagues in bringing our Mission to life every single day to enable our customers to make the world healthier, cleaner and safer. We provide our global teams with the resources needed to achieve individual career goals while helping to take science a step beyond by developing solutions for some of the world’s toughest challenges, like protecting the environment, making sure our food is safe or helping find cures for cancer.

Location/Division Specific Information

This role is a permanent, full-time role and is based at our site in Brisbane.

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.

What You’ll Do:

• 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.

Keys to Success:

Education

• Bachelor of Science (Biotechnology, Chemistry, or closely related degree).

• Post Graduate qualifications – beneficial.

Experience

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.

Knowledge, Skills, Abilities

• Specific knowledge of Bio-pharmaceutical processes, Pharmaceutical guidelines and principals of, preferred.

• Familiarity with principles of Aseptic techniques

• Knowledgeable in cGMP practices

• 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.

• Good knowledge of Microsoft applications (e.g. Excel, Word, Outlook, PowerPoint).

• Good knowledge of Smartsheets – desirable.

Benefits

• Health & Wellbeing: Join a company that prioritizes your health & wellbeing with comprehensive benefits, wellness programs, and an Employee Assistance Program providing confidential support for personal and work-related issues.

• Flexibility: Balance your work and personal life with flexible arrangements.

• Extra Leave: Benefit from generous leave policies, including the option to purchase additional leave, paid birthday leave, and company paid parental leave.

• Charitable Giving & Volunteering: Make an impact with paid volunteer time to support non-profit organizations that matter to you.

• Learning & Development: Advance your career with access to online courses via Thermo Fisher Scientific University Plus and LinkedIn learning, workshops, and mentorship programs for continuous learning and skill development.

Thermo Fisher Scientific Australia WGEA Employer of Choice for Gender Equality

Our Mission is to enable our customers to make the world healthier, cleaner and safer. Watch (https://jobs.thermofisher.com/global/en/5-reasons-to-work-at-thermo-fisher-scientific) as our colleagues explain 5 reasons to work with us. 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 (https://corporate.thermofisher.com/us/en/index.html) , where diverse experiences, backgrounds and perspectives are valued.

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.

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.