Microbiologist - Sterile Compounding

Position Title: Microbiologist - Sterile Compounding

Location: Houston, TX (No relocation available; local candidates only)

Department: Quality Control/Assurance

Reports To: Quality Control Manager

Job Type: Full-time

About Us:

Revive RX is a leading pharmaceutical company dedicated to delivering high-quality compounded medications to enhance patient care. We are committed to excellence and innovation in all aspects of our work, particularly in maintaining the highest standards of quality and safety in our sterile compounding processes.

Position Summary:

We are seeking a highly skilled and detail-oriented Microbiologist with expertise in sterile compounding. The successful candidate will play a crucial role in ensuring the microbiological quality and safety of our compounded sterile preparations. This position requires a strong understanding of microbiological testing, data analysis, and environmental monitoring in a pharmaceutical setting.

Key Responsibilities:

Microbiological Testing:

• Conduct routine and non-routine microbiological testing of sterile compounded products
• Perform environmental monitoring, including air, surface, and personnel sampling, in the compounding areas
• Analyze and interpret microbiological data to ensure compliance with established specifications and regulatory requirements
• Prepare samples for analysis while displaying good laboratory techniques to avoid cross-contamination or misidentified samples
  
  

Quality Assurance:

• Collaborate with the Quality Assurance team to ensure adherence to Good Manufacturing Practices (GMP) and other regulatory guidelines
• Participate in investigations and corrective actions for any microbiological deviations or non-conformities
• Review and approve microbiological test results, ensuring accuracy and reliability
• Follow all safety rules and regulations, conduct periodic quality audits, and prepare written reports of observations
  
  

Data Analysis:

• Maintain accurate and detailed records of all microbiological testing and environmental monitoring activities
• Utilize statistical tools and software to analyze microbiological data and trends
• Prepare comprehensive reports and presentations on microbiological findings for internal and regulatory purposes
• Provide scientific interpretation of results to supervisors and management as requested
  
  

Environmental Monitoring:

• Develop and implement environmental monitoring programs to assess the cleanliness and control of compounding areas
• Ensure proper calibration and maintenance of microbiological testing equipment
• Conduct risk assessments and recommend improvements to enhance environmental control
• Ensure all work performed strictly adheres to Company, client, ISO, and Pharmacopoeial methodologies
  
  

Training and Compliance:

• Provide training and guidance to compounding staff on aseptic techniques and microbiological best practices
• Stay current with industry trends, regulatory updates, and advancements in microbiological testing methodologies
• Participate in internal and external audits, ensuring compliance with all microbiological aspects of sterile compounding
• Research new technologies and methodologies to improve laboratory processes and techniques and make recommendations to supervisors
  
  

Qualifications:

• Bachelor's or Master’s degree in Microbiology, Pharmaceutical Sciences, or a related field
• 2-3 years of experience in microbiology, preferably in a sterile compounding or pharmaceutical setting
• Strong knowledge of microbiological testing methods, environmental monitoring, and aseptic techniques
• Proficiency in data analysis and statistical software
• Excellent attention to detail and organizational skills
• Strong communication and interpersonal skills
• Ability to work independently and as part of a multidisciplinary team
• Familiarity with regulatory guidelines (e.g., FDA, USP, cGMP) related to sterile compounding
  
  

Preferred Qualifications:

• Experience with pharmaceutical quality control and assurance
• Knowledge of current Good Manufacturing Practices (cGMP) and other regulatory requirements
• Certification in microbiology or related fields
  
  

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