Opportunity Summary
The Microbiology QC Analyst will execute a variety of responsibilities in compliance with quality standards and applicable government regulations to ensure product specifications are met.
Duties and Responsibilities
* Perform Sterility testing of products, including routine sampling and microbial analysis.
* Conduct Environmental Monitoring, incorporating viable and non-viable assessments.
* Assist in the preparation, review, and update of Standard Operation Procedures and test protocols.
* Enter data into Laboratory Information Management Systems (LIMS).
* Support the Qualification (IQ, OQ and PQ) of Sterility Isolators.
* Participate in investigations of out-of-specification results as required.
* Maintain equipment and facilities according to approved procedures.
* Ensure general laboratory housekeeping and consumables ordering.
Essential Skills and Qualifications
* Microbiological background is necessary for this role.
* A degree in Microbiology or a related science, complemented by further studies in Microbiology or equivalent experience.
* Desirable: experience within the pharmaceutical industry, particularly in laboratory settings or within Sterility Isolators.
* Familiarity with regulatory requirements such as USP/BP/EP.
* Strong aseptic techniques are essential.
* Knowledge of TGA (PICs) and FDA requirements.
* Understanding of Good Distribution Practices (GDP) and Good Laboratory Practices (GLP).
Culture and Values
Our organization fosters a culture that prioritizes improvement and the betterment of others' lives.