Quality Control Team Leader Physio-chemistry

5 months ago

Brisbane, 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

**Job Title: Senior QC Team Leader, Physiochemistry & Raw Materials**

**Reports to**: QC Operations Manager

**Group / Division**: PSG/DSD

**Career Band**: 05

**Job Family**:Operations

**Job Sub Family**:QC

**Job Code**:OPS.QCOP.P05

**Job Track**:Professional

**Position Location**: PSG Brisbane Australia

**Number of Direct Reports: 4**

**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 Laboratory is responsible for the execution of Qualification/Validation Protocols, Technical Transfer (as applicable) and Performance of Quality Control tests.

**Key Responsibilities**:

- Leading the day-to-day management of the Quality Control Physiochemistry and Raw Materials team including planning of activities and resources, execution of analysis, reporting of results, and key performance indicators
- Coaching, training, and support of other team members.
- Ensures compliance of facilities, raw materials, products and systems with international quality requirements and in line with the customer specific requirements. Timely and scientifically sound output of the Quality Control Physiochemistry Laboratory, according to regulatory requirements and cGMP.
- Sound knowledge of equipment used for execution of test records within the Physiochemistry laboratory (FTIR, RAMAN, TOC, pH, Osmolality, Conductivity, etc.). Coordinate Raw Material testing/release in accordance to relevant Pharmacopoeia (BP, EP, JP, USP, etc).
- Identify, investigate, and close non-conformances and OOS/UR on-time with high quality. Ensure compliance with cGMP and Data Integrity within team.
- Responsible for lab equipment maintenance upgrades and improvements.
- Lead and assist with PPI projects
- Perform any other legitimate duties as directed by the Operations Manager, QC (or delegate)

**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). Background in analytical theory and technical competency with laboratory analysis. Knowledgeable with cGMP and various laboratory analyses, efficient sample workflows, in process controls, analytical testing and equipment maintenance/introduction.
- Ability to work on multiple projects simultaneously.
- Strong team-working and collaborative skills. Previous experience in leadership and personnel management-desirable

**Skills & Attributes**
- Adaptability: Ability to adapt to daily business requirements.
- Collaborating: Have the ability and competency to work with all departments and colleagues of varied backgrounds.
- Continuous Improvement: Drive PPI.

**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.

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