QC Scientist I (Microbiology)

  • 50 NW 176th St, Miami, FL 33169, USA
  • Contract

Company Description

Medical Device

Job Description

  • Perform microbiological testing on raw materials, finished products and stability samples according to applicable procedures.
  • Collect environmental/utilities samples and perform analysis according to applicable site procedures. Maintain environmental trending data.
  • Assists in completing project protocols, change notifications, deviation waivers and Quality Notifications with supervision.
  • Perform assigned projects and tasks; compile testing data and review testing results.
  • Maintain Microbiology Laboratory inventory. Order supplies, reagents and materials.
  • Support equipment maintenance activities.
  • Understand lab safety and hazardous waste management.
  • Clean and maintain laboratory areas and equipment according to procedures.
  • Support investigations and implementation of corrective actions.
  • Responsible for maintaining laboratory notebooks and records according to Good Documentation Practices.
  • Perform Microbiology Lab activities as assigned by Quality Manager/Designee in order to achieve QC testing delivery goals.
  • Maintain Microbiology Lab audit readiness.

Desired Qualification:

  • Strong knowledge of quality system regulations/requirements, FDA, cGMP.
  • Good understanding of Cell culture systems, hybridomas, liquid and dehydrated media manufacturing process, aseptic and sterile fill process and systems.
  • Experience with gram negative and gram positive, anaerobic bacteria, environmental fungi identification and testing methodologies.
  • Experience with Bioburden/growth determination systems, aseptic methods and sterilization systems.
  • Strong in application of technical principles, practices and procedures.
  • Effective communication skills at all levels both written and verbal.
  • Effective skills in analytical thinking and problem solving.
  • Ability to perform multiple tasks.
  • Ability to work in teams to obtain results, self-motivated/directed, ability to organize activities, minimal supervision required.

Additional Information

All your information will be kept confidential according to EEO guidelines.