Position Summary: The Quality Control Laboratory is responsible for the execution of Qualification/Validation Protocols. Technical Transfer (as applicable) and Performance for Quality Control tests undertaken within the Quality Control Laboratory.
The QC Team Leader of Chemistry will lead the Quality Control Chemistry team, consisting of roles:
- Senior Quality Control Scientist/s (Engineer/Scientists II)
- Quality Control Scientist/s (Engineer/Scientists I)
- Senior Quality Control Technician/s
Responsibilities include assuring timely and scientifically sound output for the Quality Control Chemistry team according to International regulatory guidelines related to assay qualification/validation, in-process production samples, final formulated products and systems with International quality requirements, and in line with the customer specific requirements.
Key Responsibilities:
- The QC Team Leader of Chemistry, is responsible for day to day management of the Quality Control Chemistry Laboratory team, including planning of activities and resources, execution of analysis, reporting of results, and reporting of key performance indicators.
- The QC Team Leader of Chemistry is tasked with undertaking (but not limited to): cIEF, CE-SDS, UPLC, and HPLC.
- Establishes the goals and objectives of the team, ensuring a high level of analytical quality
- Supports client focused outcomes for the analysis of stability study samples, method analytical transfer, and qualification and validation studies to agreed timelines.
- Supporting PSG Brisbane Australia's Engineering Team on equipment maintenance and calibration.
- Assisting the Engineering and Validation Team with equipment/system upgrades and qualification.
- Peer review and technical review of analyses for completeness and cGMP compliance.
- Leads/manages the performance of the team through effective key performance indicators (KPIs), targets and goal setting.
- Ensure the effectiveness of the Quality Control Chemistry Laboratory aligns with EH&S; guidelines and Quality Standards.
- Tracking and reporting milestones, ensuring efficiencies are gained through practical process improvement (PPI).
- Assist with regulatory and client audits, representing all aspects of the QC Chemistry Team.
- Perform any other legitimate duties as directed by the Manager, QC Operations.
Frequent Contacts:
Internal
- All Internal Departments including QC, QA, and Operations
External
- Customers
- Regulatory Agencies
- Other Thermo Fisher Scientific Business both within and external to the PSG
- Equipment/Contract Laboratory/Maintenance vendors and contractors
Minimum Requirements/Qualifications:
Qualifications & Experience
- Bachelor of Science (Biotechnology, Chemistry, or closely related degree).
- Post Graduate qualifications - beneficial.
- At least 1 year of experience in a leadership role.
- At least 5 years' experience in the pharmaceutical and/or pharmaceutical industry aligned to Analytical and Quality Control fields, especially in chromatography analysis.
- Knowledgeable in cGMP practices.
- Knowledgeable with various Chemistry laboratory analyses, efficient sample workflows, in process controls and analytical testing, and area/equipment within the Quality Control Chemistry Laboratories.
- Ability to effectively communicate in multiple modalities (e.g. electronic, written, verbal, etc.)
- Good knowledge of Laboratory Information Management Systems (LIMS) - desirable.
- Good knowledge of Empower and 32 Karat - desirable.
- 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 timelines.
- Initiating Action: Demonstrates the ability to work independently and manage 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.