Supervisor, Qc Microbiology
3 months ago
**Work Schedule**
Standard (Mon-Fri)
**Environmental Conditions**
Adherence to all Good Manufacturing Practices (GMP) Safety Standards, No eye contacts allowed; prescriptive glasses will be provided, Office, Some degree of PPE (Personal Protective Equipment) required (safety glasses, gowning, gloves, lab coat, ear plugs etc.)
**About us**:
**Position Summary**:
The position entails ensuring compliance with international quality requirements set by regulatory agencies such as TGA, FDA, EMA, and others. This involves the implementation, maintenance, and execution of quality systems in the manufacturing of biopharmaceutical products. The Quality Control Laboratory plays a crucial role in executing Qualification/Validation Protocols, Technical Transfer (as applicable), and Performance for Quality Control tests.
**Key Responsibilities**:
Manage the day-to-day operations of the QC Microbiology Laboratory, including planning activities, allocating resources, conducting analyses, reporting results, and monitoring key performance indicators. Oversee environmental monitoring, including surface monitoring, active and passive air sampling. Provide support for activities related to analytical development and QC test strategy to meet client requirements. Perform growth promotion testing of microbiological media used in testing. Ensure stock control within the Microbiology laboratory, including maintaining sufficient levels of microbiological media and liaising with warehouse staff. Ensure adherence to EH&S safe working practices, including wearing personal protective equipment (PPE), conducting hazard identification, and reporting accidents, incidents, and near misses. Lead process improvement initiatives and maintain the quality of microbiological documents, including SOPs, specifications, test methods, policies, summary reports, and investigation reports. Proactively manage Change Controls, report and investigate microbiological excursions (OOS, DRs). Provide microbiological technical support and input into Quality-related issues, effectively communicating across departments and internal customers. Collaborate with the team on non-routine work and provide training and guidance to QC Microbiology staff. Contribute to regulatory and client audits, maintaining the QC Microbiology in an 'audit ready' state. Liaise and coordinate with external contract laboratories for outsourcing of necessary microbiological testing.
**Skills and Experience**
- Bachelor of Science in Biotechnology, Chemistry, or a closely related field.
- Strong analytical theory background and technical proficiency in laboratory analysis.
- Knowledge of cGMP and various laboratory analyses, efficient sample workflows, in-process controls, analytical testing, and equipment maintenance/introduction.
- Effective communication skills in multiple modalities (e.g., electronic, written, verbal).
- Ability to prioritise multiple projects simultaneously.
- Strong team-working and collaborative skills, with previous leadership and personnel management experience being desirable.
**Skills & Attributes**:
- Adaptability to daily business requirements.
- Collaboration skills to work optimally with diverse departments and colleagues.
- Commit to continuous improvement (PPI).
- Quality orientation with attention to detail and accurate completion of test records.
- Strive for right-first-time approach in every task undertaken.
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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