EngineerScientist I QC

Work Schedule

Environmental Conditions

Job Description

About us:

As part of the Thermo Fisher Scientific team youll 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 worlds toughest challenges like protecting the environment making sure our food is safe or helping find cures for cancer.

Role Location:

The role of Scientist Quality Control is based on site at our Brisbane location and is a Fixed Term 12month Contract role.

Position Summary:

Our Brisbane site is focused on the manufacturing of biopharmaceutical products and is required to be aligned with quality requirements as defined by the TGA FDA EMA and other regulatory agencies as applicable. To achieve compliance quality systems are defined implemented and maintained. The Quality Control team in Brisbane supports our clients studies that are required for the regulatory acceptance of their drug substance and drug product. Responsibilities include assuring timely accurate and scientifically sound output of data from the Stability Studies CoA/SoT generation for batch release shipment of test samples coordinating and accepting results from external third party test facilities as required for each customer project.

Key Responsibilities:

• Independently liaise with Clients and Project Managers regarding their Quality requirements for stability studies batch testing external shipments and external contract testing. Efficiently handle Client queries expectations and challenges. Supply and update relevant information and results to Project Managers and clients.
• Collaborate with QC Labs QA Program Management Warehouse and Logistics 3rd party contract labs equipment/ /Maintenance vendors and contractors
• Generate shipping documentation and sample submission forms required for testing of Client samples at external facilities. Review and approve test reports supplied from external facilities
• Perform aseptic aliquoting of bulk samples (typically from the Operations department).
• Support Quality Control laboratory teams as required to ensure relevant testing is performed on time and ensure accordance with Regulatory Guidelines in performance and guidelines for Client stability studies
• Knowledge of Change Control Deviations CAPA OOS and OOT Document Management related to the Quality Systems operating on the Brisbane site.
• Practical application of various risk assessments tools (i.e. failure mode effect analysis fishbone diagrams hazard and operability studies)
• Engage with the Quality teams (QA and QC) to ensure batch release documentation and site delivery times are met in a profitable manner
• Support PPI activities for the business
• Ensure traceability and legibility of all QC documentation and ensure effective of documentation records for client requirements
• Support generation and approval of Work Flows and MLPs in gLIMS
• Work within EH&S guidelines Corporate Quality Standards Standard Operating Procedures and data integrity maintain the Companies TGA and other manufacturing licenses
• Mentor and motivate members of the team by delivering training of QC staff as required.
• Perform any other legitimate duties as directed by the QC Team Leader (or delegate).

Keys to Success:

Education:

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

Skills & Experience:

• At least 2 years industry work experience in the pharmaceutical or biotechnology industry aligned to Analytical and Quality Control fields
• Knowledgeable with test method development qualification validation.
• Must be knowledgeable in cGMP practices and quality management systems (QMS) including experience with deviations CAPA OOS OOT document management change control etc
• Enjoy working in a highly fast paced and frequently changing environment with a wide variety of people and perspectives
• Experience in stability studies suitable for the biopharmaceutical industry
• Good attention to detail as a team member and when working independently.
• Can communicate in multiple modalities (e.g. electronic written verbal etc.
• Ability to prioritise multiple Client programs and reports simultaneously.
• Understanding of Microsoft applications (e.g. Excel Word Outlook).
• Ability to use Smartsheets
• Knowledge of LIMs Sample Manager
• Adaptability: Ability to adapt to every day business requirements.
• Collaborating: Work constructively with all departments and colleagues of multicultural backgrounds.
• Continuous Improvement: Challenge current systems to drive process improvements.
• Customer Requirements: Always deliver on promises made to customers.
• Initiating Action: Work independently and also show initiative in planned work. Ability to work on multiple projects or tasks simultaneously.
• Handling Relations: Demonstrates the ability to support customer demands within business requirements and agreed timelines.
• Quality Orientation: Ability to interpret and apply cGMP principles strong attention to detail and accurate completion of test records. Strives for right first time in every task undertaken.

Benefits:

Join our team and take advantage of these great benefits! Apply now to learn more about the full range of benefits we offer.

• Health & Wellbeing:Join a company that prioritizes your health & wellbeing with comprehensive benefits including company paid private health insurance and risk benefits insurance (via selected company provider) wellness programs and an Employee Assistance Program providing confidential support for personal and workrelated 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 nonprofit 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 as our colleagues explain 5 reasons to work with us. As one team of 100000 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.

Apply today!

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.