Microbiologist Technician

McKenna Labs, IncFullerton, CA
Onsite

About The Position

McKenna Labs is a full-service contract manufacturing company specializing in hair, skin, and body care products, operating since 1998. The Microbiologist Technician is responsible for monitoring, controlling, and preventing microbial contamination throughout the manufacturing process to ensure product quality and safety. This role ensures products meet the stringent requirements of Good Manufacturing Practices (GMPs) and other applicable standards, and is an integral part of the Quality Control Department.

Requirements

  • BA/BS degree in Microbiology, Chemistry, Biology, Biochemistry or related field.
  • Good computer skills with knowledge of Microsoft Word, Access and Excel.
  • Effective oral and written business communication skills.
  • Ability to multi-task, work effectively and complete projects in a fast-paced environment.
  • Ability to read and interpret documents such as material safety data sheets, safety rules, operating and maintenance instructions, and procedure manuals and test methods.
  • Ability to speak effectively with employees, peers, and management within the organization.
  • Ability to add, subtract, multiply, and divide in all units of measure, using whole numbers, common fractions, and decimals.
  • Ability to compute rate, ratio, percent, and calculate dilution factors.

Responsibilities

  • May perform routine microbiological testing on raw materials, in-process and finished products using compendial methods such as USP, AOAC, FDA-BAM and in-house validated methods.
  • May perform retesting of out-of-specification (OOS) results, assists with OOS investigations and OOS reports as directed.
  • May perform water sampling at various ports and performs bioburden, TOC and conductivity testing.
  • May perform Environmental Monitoring (EM) testing (for air and surface) per established test method and or approved test protocol(s).
  • May review water and EM test results and may assist with investigation of excursions and preparation of relevant reports as directed.
  • May communicate testing progress or project status to Microbiology Lab Supervisor/designee.
  • Performs timely cleaning and disinfection and handling biohazard and general waste.
  • Operates, maintains and ensures calibration of equipment including thermometers, analytical balances, pipettes and other related equipment used in the Microbiology lab.
  • May assist with new equipment qualification/validation projects.
  • Complies with cGMP, cGLP, FDA, and other applicable industry regulations.
  • Obtains samples from production and process samples for testing, including media preparation as directed or outlined in respective test protocol(s).
  • May conduct specific microbiological assays under the guidance of the Microbiology Lab Supervisor/designee.
  • Processes samples from receipt through testing, including all associated documentation and recordkeeping including data entry, helping to ensure that all steps are completed in a thorough and timely manner.
  • Adhere to and models good manufacturing practices (GMP) and good laboratory practices (GLP) at all times.
  • May participate in internal cGMP and regulatory compliance audits as necessary.
  • Maintain a clean and organized work area.
  • Maintain a positive and productive relationship with co-workers and others with whom the position may have contact.
  • Perform other duties as assigned.
  • Based on company needs, overtime is required.
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