QC Scientist I (Microbiology)
- 50 NW 176th St, Miami, FL 33169, USA
- 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.
- 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.
All your information will be kept confidential according to EEO guidelines.