SUMMARY:

This position is primarily responsible for performing microbiological tests to ensure that dietary supplement products are free of microbial contamination and safe for consumption by performing the following duties.

EDUCATIONAL QUALIFICATION:

Minimum biotech certification or associate degree in Microbiology or at least a bachelor's degree in the field; minimum five-year related experience and/or training; or equivalent combination of education and experience.

ESSENTIAL DUTIES AND RESPONSIBILITIES:

Personal responsibility for following safety rules, SOPs, and cGMP guidelines.
Train newly hired microbiologists.
Assign samples for microbial testing based on priorities set by the Quality Control head.
Ensure suitability testing is completed for all microbial samples planned for analysis.
Assist lab management in writing and handling investigations related to microbial analysis.
Test and prepare accurate daily records and documents reporting lab results for lot release.
Collect purified water samples from various loops used to manufacture dietary supplement and OTC products and send samples to an outside lab for microbial testing.
Conduct sampling as part of the Environmental Monitoring Program of the facility.
Adapt, maintain, and operate analytical instrumentation (e.g., Rapid Micro Analyzer) and perform minor equipment troubleshooting.
Document log books, in-house calibration records, etc.
Perform safety and housekeeping duties by following all safety rules, wearing required safety equipment, maintaining cleanliness during and after tasks, and keeping workstations orderly.
Draft and modify SOPs and test procedures used in the microbiology department.
Maintain monthly inventory of supplies.
Ensure all paperwork is appropriately documented.
Keep accurate attendance records.
Interpret and evaluate data regarding accuracy, precision, trends, and potential GMP impact and recommend appropriate corrective actions.
Assist in the audit process related to the microbiology department.
Perform other duties as assigned.

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Aspire Pharmaceuticals Inc

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