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Quality Control Supervisor

3 months ago

Brisbane, Queensland, Australia Thermo Fisher Scientific Full time
At Thermo Fisher Scientific, each one of our 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 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

Position Summary:


Manufacturing of biopharmaceutical products is required to be in compliance with international 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. Our team is responsible for ensuring the completion of qualification/validation protocols, batch release and stability testing. We are a
quickly expanding site with ever growing opportunities. We believe our workforce are our greatest asset, and are passionate about nurturing and developing future talent


The
Quality Control (QC) Supervisor will
lead multiple teams within Quality Control, with laboratory team leaders reporting directly into this position.


Responsibilities include assuring timely and scientifically sound output for the Quality Control teams 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:

  • Responsible for overseeing the day to day management of the Quality Control Laboratories, including planning of activities and resources, execution of analysis, reporting of results, and reporting of key performance indicators. Expected to demonstrate strong managerial proficiency in a fast paced, complex and dynamic regulated environment by managing multiple team leaders.
  • 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.
  • Assisting with the revenue goals of the Company through analytical testing outcomes and the release of drug substance (DS) and drug product (DP) results.
  • Leads/manages the performance of the team through effective critical metrics tracking and goal setting.
  • Ensure the effectiveness of the Quality Control Laboratories align with EH&S guidelines and Quality Standards. Strong engagement to lead and promote PPI
  • Build and nurture a high performing team through daytoday coaching and leadership and ensuring growth and development of the Quality Control team with a focus on building talent depth and succession planning.
  • Monitors new technologies which are relevant to the QC department that may offer more cost effective and robust solutions for the company.
  • Assist with regulatory and client audits, representing all aspects of the QC Team.
  • Deputise for the QC Operations Manager when they cannot be present as well as demonstrate leadership and accountability.
  • Ensures the scientific integrity of the QC Teams is maintained, working closely with the data integrity officer.
  • Facilitates and monitors atypical, out of specification or out of trend investigations with the team to ensure swift resolution, with facilitating an appropriate resolution.
  • Perform any other legitimate duties as directed by the QC Operations Manager

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:
  • Bachelor of Science (Biotechnology, Chemistry, Microbiology or closely related degree). Post Graduate qualifications
  • beneficial.
  • At least 2 years 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.
  • Expertise with method transfer and qualification or validation.
  • Knowledgeable in cGMP practices.
  • Strong background in analytical theory and technical competency with laboratory analysis.
  • Ability to work in a highly dynamic, frequently changing environment with a wide variety of people and perspectives, working on multiple projects simultaneously.
  • Ability to effectively communicate in mul