Microbiologist I, Quality Control
7 months ago
**Reports to**:Microbiology Supervisor,** **Quality Control
**Position Summary**:
As Microbiologist I, Quality Control, at OmniaBio, you are a motivated individual in the field of quality control (QC) microbiology for Good Manufacturing Practices (GMP) manufacturing. The QC team is responsible for all aspects of QC for the organization and the Microbiologist I, Quality Control, will be required to work across the entire range of activities, including, but not limited to, maintaining the environmental conditions in our clean rooms by performing environmental monitoring (EM), testing, sample management, method suitability and data review. You will demonstrate flexibility within the quality and larger organization, flowing to work priorities, as required. EM is an enabling function and, as such, this role will support production and facility needs to ensure product supply to patients. You will ensure the high-quality delivery of contract services.
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**Responsibilities**:
- Delivers QC microbiology-related services to various cell and viral product-centred clients, as contracted.
- Collaborates with Production, Manufacturing Science and Technology (MSAT), Facilities and QC teams in the preparation of the EM strategy and execution.
- Executes the EM schedule.
- Performs material testing in compliance with approved and current specifications, including, but not limited to, incoming materials, in-process materials, drug substance materials, drug product materials, EM samples and stability samples.
- Adheres to the QC documentation (QMS) program, including SOPs, log books and associated forms.
- Maintains the sample management program, including sample identification, storage and retention.
- Maintains equipment log books/records and a preventative maintenance schedule for applicable equipment.
- Performs aseptic gowning qualification and supports the maintaining of personnel qualifications.
- Provides in-suite and on-the-floor support for OmniaBio’s manufacturing teams, ensuring a compliant and fast-to-patient mindset. Plans and executes EM sampling for all in-suite activities. Collaborates with peers on the Production, QC and Facility teams to develop solutions to remediate compliance and quality issues.
- Performs room status updates and ensures all EM documentation is complete and available for approval.
- Participates in internal, client and health authority audits, as required.
- Prepares deviations, corrective and preventative actions, change controls, etc.
- Ensures GMP is embedded in all manufacturing-related tasks.
- Engages and supports the OmniaBio Operating Model continuous improvement philosophy.
- Continuously grows and adapts in a fast-moving field to keep yourself and the organization at the forefront of the cell and gene therapy and regenerative medicine fields.
- Represents OmniaBio and promotes its mission and capabilities to the cell and gene therapy field through participation at conferences, symposia, other venues and customer visits.
**Requirements**:
- High school and 1+ year in a science program (bioengineering, bioprocess, biotechnology, cell biology, microbiology, etc.).
- Minimum 1 year of practical and related experience and/or 6 months on-the-job training in a cell therapy/viral quality department supporting GMP production or similar, within the pharmaceutical, medical technologies, biologics, or similar industries.
**Desired Characteristics**:
- Independent, detail-oriented, self-starter with the ability to multitask and succeed in a team environment.
- Demonstrate initiative and able to deliver high-quality outcomes.
Revision Number: QCMBI-20240610
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