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Bioidentical Medication Specialist
2 weeks ago
We are seeking a skilled Bioidentical Medication Specialist to join our team at FarmaKeio Outsourcing, an FDA-registered 503B outsourcing facility in Southlake, TX.
The ideal candidate will have a strong background in microbiology and experience in a pharmaceutical or 503B environment. The role will involve performing microbiological testing, ensuring compliance with regulatory requirements, and collaborating with cross-functional teams to maintain quality standards.
This is an on-site position with a salary of $65,000 - $85,000 per year, offering opportunities for growth and development in a dynamic environment.
About the RoleKey Responsibilities:
- Microbiological Testing: Conduct sterility testing, endotoxin testing, microbial limit testing, and environmental monitoring to ensure compliance with 503B and USP standards.
- Quality Assurance Control: Monitor and maintain microbiological quality throughout the compounding and manufacturing processes, reviewing test results and reporting findings.
- Environmental Monitoring: Conduct routine assessments of cleanrooms and production areas to ensure adherence to cleanliness and sterilization protocols.
- Documentation Compliance: Accurately document all microbiological tests, environmental monitoring results, and corrective actions in accordance with cGMP and FDA guidelines.
To be successful in this role, you will need:
- A Bachelor's degree in Microbiology, Biology, or a related field.
- Minimum 3-5 years of experience in a microbiology laboratory setting, preferably in a pharmaceutical or 503B environment.
- Solid understanding of microbiological testing methods, sterility assurance, endotoxin testing, and environmental monitoring.
- Familiarity with regulatory guidelines such as USP and FDA compliance.
- Strong attention to detail and accuracy in all aspects of testing, documentation, and reporting.
- Excellent written and verbal communication skills to present complex data clearly.
- A commitment to maintaining regulatory compliance, patient safety, and quality standards.
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