Microbiologist

Job Description

JOB QUALIFICATIONS:

• Bachelor’s degree in Biology, Microbiology, discipline with two years’ experience in a relevant Microbiology laboratory environment (e.g. Pharmaceutical, Quality, Clinical, sterile manufacturing or lab operation) or Master Degree in Biology, Microbiology
• Thorough knowledge and understanding of current Good Manufacturing Practices (cGMP), FDA Guidance, and ICH Guidelines
• Strong microbiology skills with a focus on drug product contamination control and environmental microbiology
• Experience in the use and handling of standard instrumentation used for Microbiological and EM sampling and testing
• Experience in regulated/cGMP environment highly preferred
• Experience working with Quality Systems in GMP regulated operations such as Change Control, Deviation / Investigation, CAPA’s and other quality systems
• Time management and prioritization
• Excellent oral and written communication
• Attention to detail and ability to perform job function with minimal supervision
• Critical thinking, problem solving, and analytical thinking applied to data and diverse situations
• Proficient in computer applications (Word, Excel and Power Point)
  
  

POSITION RESPONSIBILITIES:

• Collects samples from a variety of locations
• Coordinate sample shipping to external laboratories, coordinate testing schedule and review /approve test results.
• Run the Environmental Monitoring Program (EM) in terms of Test & Data Management
• Run the Purified Water (PW) Monitoring Program in terms of Test & Data Management.
• Perform Environmental Monitoring tasks as needed.
• Generate quarterly EM and PW reports
• Lead EM excursion Deviations and associated CAPAs
• Provide technical Support (from Microbiology and Aseptic Technics perspective) to Manufacturing operation.
• Develop Risk assessment from Micro/EM perspective to support changes to the controlled areas and/or process that are conducted on it.
• Function as the Micro Laboratory liaison and subject matter expert (SME) to other department representatives, customers and regulatory representatives.
• Provides remediation solutions to Laboratory and operations area on Microbiology related issues
• Scheduling Micro laboratory equipment maintenance, calibration and repairs ensuring minimum impact to the Lab and Manufacturing
• Contact person with Laboratory Service provider company
• Perform all other tasks that will be oriented by the QC Supervisor, QC Manager or the Quality Director
  
  

PHYSICAL REQUIREMENTS:

• Work safely and follow all OSHA regulations and company safety policies and procedures
• Works frequently in a lab environment, handling of chemicals
• Employees are required to wear eye protection and lab coats while in the lab area
• Ability to frequently lift and/or move up to 25 lbs
• Ability to occasionally lift and/or move up to 35 lbs
• Ability to regularly stand, sit, and walk to perform tasks
  
  

Company Description

PL Developments is an over-the-counter pharmaceutical manufacturing and packaging company, headquartered in New York. We have an excellent work environment, truly invest in our people, and believe in great work/life balance. We offer a comprehensive benefits package.

PLD participates in E-Verify and will provide the federal government with your Form I-9 information to confirm that you are authorized to work in the U.S.

PL Developments is an over-the-counter pharmaceutical manufacturing and packaging company, headquartered in New York. We have an excellent work environment, truly invest in our people, and believe in great work/life balance. We offer a comprehensive benefits package. PLD participates in E-Verify and will provide the federal government with your Form I-9 information to confirm that you are authorized to work in the U.S.