Engineer/Scientist I, QC Customer Programs
Pharmaceutical Product Development (PPD)
Brisbane, Queensland, Australia
Job Description
At Thermo Fisher Scientific, each one of our 75,000 extraordinary minds has a unique story to tell. Join us and contribute to our singular mission—enabling our customers to make the world healthier, cleaner and safer.
When you’re part of the team at Thermo Fisher Scientific, you’ll do important work. Surrounded by collaborative colleagues, you’ll have the support and opportunities that only a global leader can give you. Our respected, growing organization has an exceptional strategy for the near term and beyond. Take your place on our strong team, and help us make significant contributions to the world.
Job Title: QC Scientist - QC Customer Programs
Reports to: Team Leader, QC Customer Programs
Group / Division: PSG/DSD
Career Band: 04
Job Family: Operations
Job Sub Family: Quality Control
Job Code: OPS.QCOP.P04
Job Track: Professional
Position Location: PSG Brisbane Australia
Number of Reports: None
Position Summary:
Manufacturing of biopharmaceutical products 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 Customer Programs team supports the vital studies that are required by the customer for the regulatory acceptance of their drug substance and drug product. Responsibilities include assuring timely and scientifically sound output of data from the Stability Studies, CoA/SoT generation for batch release, shipment of test coordinating and accepting results from external third party test facilities, as scoped for each customer project requirements
Key Responsibilities:- Independently liaise with Cients and Project Managers regarding stability studies, external shipments and 3rd party contract testing. Confidently handle Client queries, expectations and challenges. Supply and update relevant information and results to Project Managers and Clients.
- Prepare and approve documentation including Stability Protocols and Statements of Testing, Stability Summary Reports Batch Release CoAs and SoTs, External Test Report, shipping documentation and sample submission forms.
- Demonstrate an understanding of the Quality Control practices and principles.
- Support the laying down and pulling of samples for Client product stability studies.
- Support and provide guidance in the shipping and documentation requirements for testing of Client samples at external facilities. Review and approve results supplied from external facilities.
- Support the generation and approval of batch release documentation (CoA) and in-process documentation (SoT) for Client product to facilitate on time delivery.
- Practical application of the Quality System, Change Control, Deviations, CAPA, OOS and OOT, Document Management, related to the Quality Control Department.
- Practical application of various risk assessments tools (i.e. failure mode effect analysis, fishbone diagrams, hazard and operability studies).
- Independently initiate activities ensuring adherence to EH&S.
- Ensures the scientific integrity is maintained by working closely with the data integrity officer.
- Work directly with the program management teams to ensure stability studies and external shipments/testing contractual stages and timelines for customer projects are met.
- Work directly with the program management team, QA and QC teams to ensure batch release documentation and site expectations are maintained in the most profitable way.
- Work directly with the program management team to ensure customer satisfaction and expectations are maintained.
- Identify and report non-conformances directly to Supervisor and QC Manager or delegate.
- Author and review protocols and reports in line with Patheon Brisbane internal policies and regulatory guidelines.
- Support QC laboratory teams as practical to ensure relevant testing is performed on time.
- Ensure effective delivery of high quality stability studies for clients.
- Prepare data to support specification discussions and present in specification council meetings.
- Monitors new regulatory requirements which are relevant to QC Customer Programs and may offer more efficient solutions to the business.
- Ensure traceability and legibility of all QC documentation.
- Ensure effective execution of documentation records for client requirements.
- Support accurate inventory control of QC stability samples.
- Support receipting of samples into LIMS.
- Perform aseptic aliquoting of stability samples.
- Support printing and checking of sample labels for test aliquots.
- Maintain work areas in accordance to aseptic requirements.
- Liaise with the Engineering Department to arrange routine equipment maintenance as per MEX.
- Routine replenishment of laboratory supplies.
- Perform general housekeeping duties within the QC Laboratory.
- Work within EH&S guidelines, Corporate Quality Standards, Standard Operating Procedures and data integrity.
- Contribute to the maintaining of TGA and other licenses.
- Perform any other legitimate duties as directed by the Manager, QC (or delegate).
Frequent Contacts:
- Independently liaise with Cients and Project Managers regarding stability studies, external shipments and 3rd party contract testing. Confidently handle Client queries, expectations and challenges. Supply and update relevant information and results to Project Managers and Clients.
- Prepare and approve documentation including Stability Protocols and Statements of Testing, Stability Summary Reports Batch Release CoAs and SoTs, External Test Report, shipping documentation and sample submission forms.
- Demonstrate an understanding of the Quality Control practices and principles.
- Support the laying down and pulling of samples for Client product stability studies.
- Support and provide guidance in the shipping and documentation requirements for testing of Client samples at external facilities. Review and approve results supplied from external facilities.
- Support the generation and approval of batch release documentation (CoA) and in-process documentation (SoT) for Client product to facilitate on time delivery.
- Practical application of the Quality System, Change Control, Deviations, CAPA, OOS and OOT, Document Management, related to the Quality Control Department.
- Practical application of various risk assessments tools (i.e. failure mode effect analysis, fishbone diagrams, hazard and operability studies).
- Independently initiate activities ensuring adherence to EH&S.
- Ensures the scientific integrity is maintained by working closely with the data integrity officer.
- Work directly with the program management teams to ensure stability studies and external shipments/testing contractual stages and timelines for customer projects are met.
- Work directly with the program management team, QA and QC teams to ensure batch release documentation and site expectations are maintained in the most profitable way.
- Work directly with the program management team to ensure customer satisfaction and expectations are maintained.
- Identify and report non-conformances directly to Supervisor and QC Manager or delegate.
- Author and review protocols and reports in line with Patheon Brisbane internal policies and regulatory guidelines.
- Support QC laboratory teams as practical to ensure relevant testing is performed on time.
- Ensure effective delivery of high quality stability studies for clients.
- Prepare data to support specification discussions and present in specification council meetings.
- Monitors new regulatory requirements which are relevant to QC Customer Programs and may offer more efficient solutions to the business.
- Ensure traceability and legibility of all QC documentation.
- Ensure effective execution of documentation records for client requirements.
- Support accurate inventory control of QC stability samples.
- Support receipting of samples into LIMS.
- Perform aseptic aliquoting of stability samples.
- Support printing and checking of sample labels for test aliquots.
- Maintain work areas in accordance to aseptic requirements.
- Liaise with the Engineering Department to arrange routine equipment maintenance as per MEX.
- Routine replenishment of laboratory supplies.
- Perform general housekeeping duties within the QC Laboratory.
- Work within EH&S guidelines, Corporate Quality Standards, Standard Operating Procedures and data integrity.
- Contribute to the maintaining of TGA and other licenses.
- Perform any other legitimate duties as directed by the Manager, QC (or delegate).
Frequent Contacts:
Internal
- Quality Control Laboratories
- Quality Assurance
- Program Management
- Logistics and Warehouse
- Process Engineering
- Maintenance/Engineering
External- Customers
- Regulatory Agencies
- Other Thermo Fisher Scientific Business both within and external to the PSG
- 3rd Party Contract Laboratory
- Equipment/ /Maintenance vendors and contractors
Minimum Requirements/Qualifications:
- Customers
- Regulatory Agencies
- Other Thermo Fisher Scientific Business both within and external to the PSG
- 3rd Party Contract Laboratory
- Equipment/ /Maintenance vendors and contractors
Minimum Requirements/Qualifications:
Qualifications & Experience
- Bachelor of Science (Bio-Technology, Chemistry, or closely related degree).
- Post Graduate qualifications – beneficial.
- At least 2 years’ experience in the the pharmaceutical and/or pharmaceutical industry aligned to Analytical and Quality Control fields.
- Knowledgeable with test method development, qualification, validation.
- Knowledgeable in cGMP practices
- Ability to work in a highly dynamic, frequently changing environment with a wide variety of people and perspectives.
- Experience in laboratory testing techniques, stability studies and reference standards suitable for the bio-pharmaceutical industry.
- 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.
- Strong team-working and collaborative skills.
- Good knowledge of Microsoft applications (e.g. Excel, Word, Outlook, PowerPoint).
- Good knowledge of Smartsheets – desirable.
Skills & Attributes- Adaptability: Ability to adapt to day to day business requirements.
- Collaborating: Demonstrates the ability to work with all departments and colleagues of varied backgrounds.
- Continuous Improvement: Demonstrates the ability to challenge the status quo to drive PPI.
- Customer Focus: Demonstrates the ability to deliver on promises made to customers i.e. meet agreed due dates.
- Initiating Action: Demonstrates the ability to work independently, and lead planned work. Ability to work on multiple projects or tasks simultaneously.
- Managing Relations: Demonstrates the ability to manage customer demands with respective 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.
Other Job Requirements:
- Adaptability: Ability to adapt to day to day business requirements.
- Collaborating: Demonstrates the ability to work with all departments and colleagues of varied backgrounds.
- Continuous Improvement: Demonstrates the ability to challenge the status quo to drive PPI.
- Customer Focus: Demonstrates the ability to deliver on promises made to customers i.e. meet agreed due dates.
- Initiating Action: Demonstrates the ability to work independently, and lead planned work. Ability to work on multiple projects or tasks simultaneously.
- Managing Relations: Demonstrates the ability to manage customer demands with respective 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.
Other Job Requirements:
Deliver the best technical and scientific solutions to improve product value. Build a culture of engagement, accountability and a shared commitment to excellence. Abide by all EH&S policies and procedures, operate our business in a safe, focused, responsible, and ethical fashion. Work safely and only perform tasks if currently competent and/or authorised, participate in EH&S activities such as; GEMBA walks, inspections, and risk assessments.
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 posted: 2024-03-03
