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Support Officer – Quality Assurance and Training

Thermo Fisher Scientific

Job Description

Job Title: Support Officer – Quality Assurance and Training

Requisition ID: 137776BR

Location: Brisbane - Woolloongaba

Reports to: Training Lead and QA Manager

12 Months Fixed Term Contract – Part time

When you join us at Thermo Fisher Scientific, you’ll be part of a smart, driven team that shares your passion for exploration and discovery. With revenues of more than $25 billion and the largest investment in R&D in the industry, we give our people the resources and opportunities to make significant contributions to the world.

Location/Division Specific Information

At the Brisbane Pharma Services Group (PSG) Biologics site, we are a contract manufacturing organization (CMO) specialising in the production of biopharmaceuticals from mammalian cell culture. We supply manufacturing services including limited process development and contract “good manufacturing practice” (cGMP) grade drug substance to customers around the globe. These state-of-the-art medicines help cure cancer, rheumatoid arthritis, wet amacular degeneration and other chronic and acute diseases.

How will you make an impact?

This is a dual role supporting the training and Quality Assurance (QA) teams. You will collaborate closely with the site qualified training teams and manage the Learning Management Systems (LMS) for new and existing employees. Additionally, you will provide key Quality Assurance (QA) reporting to site and global teams.

What will you do?

Quality Assurance

  • System Administration and data for the site
  • Responsible for Brisbane KPI reporting to Corporate
  • Perform weekly and monthly reporting to Site leadership
  • Vendor Management
  • Send the questionnaires and follow up as per the External Audit Schedule
  • Assist with audit plans for internal audits
  • Assist with regulatory and customer audits
  • Assist with the roll-out of training initiatives
  • Administrative takes within the Learning Management System (LMS)
  • Updating training items, and generating various training reports
  • Creates On-line/ Skills based trainings, including assessments
  • Facilitate onboarding/induction Training for new hires
  • Scheduling training sessions
  • Provides site support to training improvement initiatives consistent with a cGMP environment

How will you get here?

Qualifications & Experience
  • Minimum of 1 year relevant experience in a (bio) pharmaceutical company or demonstrated and transferrable skills from other industries.
  • Certificate IV in Workplace Training and Assessment or equivalent work experience
  • Previous experience using Learning Management Systems
  • Experience within a GMP environment or exposure to a manufacturing or quality environment preferred.
  • Experience with data analysis is preferred

Skills & Attributes
  • Use and strong understanding of MS Excel, Word, PowerPoint tools and Learning Management System skills
  • Knowledge of pharmaceutical cGMP quality systems, international cGMP regulations and guidelines is preferred
  • Strong analytical skills and experience managing data sets is required
  • Ability to plan, organize and prioritise tasks within a dynamic working environment
  • Excellent attention to detail in data processing and preparation
  • Ability to work autonomously as well as part of a small team

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.Job