Microbiologist jobs in Kansas

Plastikon Healthcare is looking for a Microbiologist who will perform day-to-day activities relating to the microbiological, environmental, and quality processes and practices at the site applicable to the company’s regulatory and statutory requirements. This position provides testing and technical support for environmental monitoring, sterility, endotoxin, particulate monitoring, and other methods as assigned. The incumbent will support pharmaceutical and medical device manufacturing operations under the direction of the Quality Control (QC) Manager. The incumbent is responsible for following company policies, cGMPs, and all Standard Operating Procedures as mandated for this position.

Job Description:

• Provide technical knowledge for sterilization processes in conjunction with support in the resolution of plant challenges, method development, and project work.
• Individuals can be able to perform EMs, Bioburden tests, sterility tests, and other tests as assigned without supervision.
• Individuals must know about performing pH, conductivity, and media preparation as well.
• Conduct testing per schedules for the timely release of products and materials in alignment with the business goals and priorities.
• Provide oversight and technical knowledge to ensure the pharmaceutical site cleaning and disinfection program is adequate to ensure control of the cleanroom environment to applicable company, regulatory, and statutory requirements.
• Support activities as assigned by QC Management to facilitate testing, qualification, system improvements, and compliance [Change Controls, CAPA, Out of Specification (OOS), Validation documents, Laboratory Investigations, and Standard Operating Procedures].
• Conduct sampling and testing to ensure proper microbiological monitoring of plant utility systems, including routine trend analysis.
• Provide oversight and technical knowledge in developing solutions to environmental, particulate, microbial, and sterilization challenges for the site and the QC Lab.
• Maintains a safe and healthy work environment by following standards and procedures and complying with legal regulations.
• Operate in compliance of cGMP, 21CFR and USP regulatory requirements.
• Other duties as assigned.

ESSENTIAL FUNCTIONS

Reasonable Accommodations Statement

To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. Reasonable Accommodations may be made to enable qualified individuals with disabilities to perform the essential functions.

POSITION QUALIFICATIONS

• A minimum of 2 years’ experience in a pharmaceutical/medical device or quality control role, operating in an FDA-regulated GMP environment.
• Flexibility and ability to manage multiple and competing priorities.
• Ability to multi-task with a strong sense of urgency; ability to meet deadlines.
• Self-motivated, dependable, well organized, and able to communicate effectively and efficiently, both orally and in writing.
• Must hold excellent problem-solving skills.
• Excellent attention to detail and capable of performing dependable, accurate work.
• Bachelor’s degree from an accredited college or university in microbiology or related science field.

LANGUAGE SKILLS

Required reading, writing, and speaking fluently in English.

PHYSICAL DEMANDS

While performing the responsibilities of the job, the employee is required to talk and listen. The employee is required to sit, stand, walk, reach with arms and hands, lift objects, and use their hands and fingers to handle or feel. The employee is occasionally required to climb or balance, stoop, kneel, crouch, or crawl. Vision abilities required by the job include close vision. Reasonable accommodation may be made to enable individuals with disabilities to perform essential functions.

WORK ENVIRONMENT

The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. Reasonable accommodation may be made to enable individuals with disabilities to perform essential functions.