Microbiologist I

Description

Driven by a commitment to research, quality and service, PDI provides innovative products, educational resources, training and support to prevent infection transmission and promote health and wellness. Encompassing 3 areas, our Healthcare, Sani Professional and Contract manufacturing divisions, we develop, manufacture and distribute leading edge products for North America and the world. We have several locations across the US and are looking for new Associates to join our team!

POSITION PURPOSE

Part of the Quality Control department that evaluates raw materials, other supplies and the finished, packaged product and ensures compliance to Good Manufacturing Practices. Provides support to the operations and manufacturing departments to ensure safe and effective finished product release.

ESSENTIAL FUNCTIONS AND BASIC DUTIES

Conducts routine microbiological testing and analysis for water; bulk pharmaceutical chemicals and drug products; collects samples; prepares standards/controls, media and sample solutions; and maintains appropriate records.

TESTING & ANALYSIS:

• Collects purified water samples from the various USP Purified Water Loops used to manufacture or test drug products
  
• Prepares media used in the microbiological testing of bulk pharmaceutical chemicals, drug products and components.
  
• Perform growth promotion testing for purchased and prepared media
  
• Samples raw materials and/or finished products for microbial testing
  
• Performs microbiological testing on water, bulk pharmaceutical chemicals, drug products and components, finished products
  
• Collects environmental samples for microbiological analysis
  
• Conduct aseptic samplings for evaluation of compressed air and cleaning/sanitization processes
  
• Perform basic identification of microorganisms (Gram stain)
  
• Maintain the cleanliness and organization of the laboratory
  
• Prepares samples for shipment to outside contract laboratory for microbiological testing
  
• Performs related support activities and duties as assigned.
  
  TECHNICAL:
  
• Follow all Current Good Manufacturing Practices (cGMP), Food and Drug Administration (FDA) and other regulatory requirements
  
• Perform laboratory tasks using general microbiological laboratory techniques and procedures
  
• Follow internal sampling methods and quality control systems
  
• Perform general mathematics (addition/subtraction/multiplication/division, dilutions, proportions, percentages)
  
• Utilize and understand computer applications and programs (Word, Excel, Office 365, LIMS)
  

PERFORMANCE MEASUREMENTS

• Annual Goals and Objectives
  
• Right first time Metrics
  
• Training documentation
  
• Qualification for performing test methods
  

QUALIFICATIONS

EDUCATION/CERTIFICATION:

• Bachelors degree in Biology or related science from an accredited college or university

REQUIRED KNOWLEDGE:

• Be able to read, write and speak English
  
• Read and comprehend Company policies and procedures, including safety rules and regulations
  

EXPERIENCE REQUIRED:

• A minimum of 0-1 year of related laboratory work experience in a pharmaceutical environment, or an equivalent combination of training and experience.

SKILLS/ABILITIES:

• Ability to multi-task and have good time management skills.
  
• Must have good communication and customer service skills.
  

WORKING CONDITIONS

REQUIRED PPE

• Incumbents in this class are subject to extended periods of sitting, standing, walking, lifting materials weighing up to 30 pounds, vision to monitor and moderate to loud noise levels.
  
• Incumbents may be exposed to or work with toxic materials, toxic gases, electrical hazards, dangerous tolls and equipment. Work is performed in laboratory environment. Incumbents must be able to use personal protective equipment (e.g. respirators, gloves, etc)
  

Equal Opportunity Employer/Protected Veterans/Individuals with Disabilities

The contractor will not discharge or in any other manner discriminate against employees or applicants because they have inquired about, discussed, or disclosed their own pay or the pay of another employee or applicant. However, employees who have access to the compensation information of other employees or applicants as a part of their essential job functions cannot disclose the pay of other employees or applicants to individuals who do not otherwise have access to compensation information, unless the disclosure is (a) in response to a formal complaint or charge, (b) in furtherance of an investigation, proceeding, hearing, or action, including an investigation conducted by the employer, or (c) consistent with the contractors legal duty to furnish information. 41 CFR 60-1.35(c)