Turbare Manufacturing, LLC Microbiologist Conway, AR · Full time

Overview: Turbare Manufacturing LLC is a 503B outsourcing facility, a compounding pharmacy that is regulated by the U.S. Food and Drug Administration (FDA). Our facility is responsible for producing sterile preparations in large volumes for use in healthcare facilities. Microbiologists play an important role in ensuring the safety, efficacy, and quality of pharmaceutical products by monitoring and controlling microbial contamination throughout the manufacturing process.

Description

Primary Purpose: 

Microbiology is a crucial area of focus for Turbare Manufacturing LLC, as many of our sterile preparations are used in hospital and healthcare settings or come into contact with the human body. Microbiologists play a key role in ensuring that these products are free from harmful microorganisms and meet regulatory requirements. Overall, the job of a microbiologist at Turbare Manufacturing LLC is an important and challenging role that requires a strong foundation in microbiology, as well as excellent analytical, communication, and problem-solving skills. The microbiologist is expected to implement robust quality control measures, conduct thorough testing and ensure adherence to USP<797> industry regulations and standards. Their expertise will help to prevent microbial contamination, safeguard patient health, and maintain the integrity of pharmaceutical products. 


Essential Duties and Responsibilities

The essential functions include, but are not limited to the following:

 

Essential Function and Responsible:  

1.   Quality Control: Microbiologists will be responsible for ensuring that medications are free from harmful microorganisms and meet regulatory requirements for sterility and potency. This could involve conducting microbiological testing of raw materials, finished products, and environmental samples, and analyzing test results to identify potential risks to product safety. 

 

2.   Regulatory Compliance: Microbiologists will be required to stay up to date on relevant regulations and standards for pharmaceutical manufacturing and ensure that the facility is in compliance with these requirements. They may participate in audits or inspections to demonstrate compliance and may work with regulatory agencies to address any deficiencies or issues. 

 

3.    Process Improvement: Microbiologists in 503B outsourcing facilities may participate in cross-functional teams to identify opportunities for process improvement, such as developing new testing methods or implementing new quality control measures. They may also be responsible for developing and maintaining standard operating procedures related to microbiological testing and quality control. They may participate in cross-functional teams to develop new products or improve existing ones and are expected to contribute to continuous improvement efforts across the organization. 

 

4.   Education and Training: A microbiologist in a 503B outsourcing facility has a degree in microbiology as well as relevant training or certification in quality control, laboratory safety, or other relevant areas. They should have a strong understanding of microbiological principles and techniques, as well as a working knowledge of regulatory requirements for pharmaceutical manufacturing. 

 

5.   Collaboration: Microbiologists in 503B outsourcing facilities work closely with other functions within the facility, such as product development, manufacturing, and quality control. They may also collaborate with external partners, such as contract testing laboratories or regulatory agencies, to address microbiological challenges. 

 

Minimum Qualifications (Knowledge, Skills, and Abilities)


1.   Must have a degree in microbiology. They may also have additional certifications or training in quality control, laboratory safety, or other relevant areas. In addition, they should have experience working in a laboratory setting, preferably in the consumer products industry.

2.   Developing and implementing environmental monitoring programs: Microbiologists can design environmental monitoring programs that are specific to the needs of the 503B facility. These programs should include sampling plans, testing methods, and acceptance criteria for environmental monitoring.  

3.   Conducting environmental monitoring testing: Microbiologists can perform environmental monitoring testing to detect and quantify microbiological contamination in the 503B facility's air, surfaces, water, and personnel. They can use various methods, such as swabbing, air sampling, settle plate, and contact plate methods, to detect the presence of bacteria, fungi, and other microorganisms. 

4.   Interpreting environmental monitoring results: Microbiologists can analyze the data generated from environmental monitoring testing to determine whether the 503B facility is meeting the required standards for cleanliness and sterility. They can also identify trends and patterns in the data that may indicate potential sources of contamination. 

5.    Implementing corrective and preventive actions: Microbiologists can assist in developing corrective and preventive actions (CAPAs) to address any environmental monitoring deviations or non-conformances. They can also provide recommendations to improve the 503B facility's environmental monitoring program. 



Physical Demands and Work Environment

The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this position. Reasonable accommodation may be made to enable individuals with disabilities to perform the functions.

·       Must be able to remain in a stationary position for long periods of time.

·       Needs to occasionally move about the office to access equipment.

·       May include minor lifting.

 

 

Note

This job description in no way states or implies that these are the only duties to be performed by the employee(s) of this position. Employees will be required to follow any other job-related instructions and to perform any other job-related duties requested by any person authorized to give instructions or assignments. All duties and responsibilities are essential functions and requirements and are subject to possible modification to reasonably accommodate individuals with disabilities. To perform this job successfully, the employee(s) will possess the skills, aptitudes, and abilities to perform each duty proficiently. The requirements listed in this document are the minimum levels of knowledge, skills, or abilities. This document does not create an employment contract, implied or otherwise, other than an at-will relationship.