QC Microbiologist

About the Job

The Microbiologist I is responsible for supporting plant-wide remediation activities and continuous improvement efforts with a focus on method development and validation. Plan and execute projects aimed at improving the compliance profile as well as function as Subject Matter Expert, contributing to audit-readiness. Perform routine testing and per review as needed.

• Adhere to SOPs and regulatory requirements such as GMPs, GDPs, GLPs and OSHA regulations.
• Perform microbiological testing and method validation related for the following microbiological test methods:
  • Sterility Testing per USP
  • Antimicrobial Effectiveness Testing (AET) per USP < 51>
  • Endotoxin per USP
  • Particulate Matter per USP ,
  • Water for Pharmaceutical Purpose
• Microbiological growth promotion
• Experience with Preservative Efficacy Testing a plus
• Adhere to controlled substance requirements
• Receive, and release media, buffers, and microorganism cultures
• Update and review microbiological trending
• Compose, update, and review procedures and training materials
• Review / record daily temperature readings
• Sanitize the laboratory incubators and refrigerators
• Review media, material, and supply inventories
• Maintain and coordinate equipment / instrumentation maintenance, calibration, and repair work
• Clean and sanitize the microbiology laboratory rooms surfaces and equipment

• A bachelor’s degree in a science field and 4-6 years in pharmaceutical quality control or combination of QC and other pharmaceutical quality experience. (graduate school may be considered toward experience)
• Knowledge of cGMP/GLP/GDP, USP, FDA regulatory requirements
• Experience performing microbiological testing / environmental monitoring using aseptic techniques
• Excellent interpersonal communication and organizational skills
• Qualified to work with controlled substances
• Knowledge and experience performing serial dilutions
• Experience Handling Biohazardous materials
• Ability to interpret technical documents
• Ability to draft or edit SOPs as needed
• Knowledge of analytical support activities for production support and validations
• Ability to conduct OOS investigations with lab management and other functional areas
• Ability to perform method development activities independently
• Ability to establish priorities, work independently and proceed with objectives without supervision
• Ability to manage project work while managing daily duties and completing all on time
• Ability to adapt to new or updated processes
• Ability to work with a variety of lab equipment such as would be used for above listed responsibilities
• Ability troubleshoot problems with analytical equipment and perform or suggest appropriate actions
• Proficiency in technical writing with an emphasis of deviations, CAPAs, etc.
• Project Management experience a plus
• Must be comfortable interacting within multiple areas of an organization and be able to communicate technical content in a concise and clear manner

We offer a dynamic environment where talent and ambition can develop to its fullest. We have an open and informal organization culture, where individuals need to have strong motivation and ability to work independently. Fagron is a widely expanding, international, professional, and ambitious pharmaceutical company with multiple growth opportunities. Job opportunity includes competitive salary, comprehensive benefits, performance package, and ability to be part of an international leader in an expanding industry.

Fagron US is committed to creating a diverse environment and is proud to be an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race; creed; color; religion; national origin; sex; age; disability; sexual orientation; gender identity or expression; genetic predisposition or carrier status; veteran, marital, or citizenship status; or any other status protected by law.

Fagron US is proud to be an affirmative action and equal opportunity employer