Boston Metro Area, Massachusetts
The candidate main responsibility will be group support under GMP compliance. After complete training and qualification, he/she will be involved in testing of quality control samples and QC stability testing using enzyme activity assays on dried blood spots following approved SOPs. He/She will be responsible to initiate/investigate and closing deviations in TrackWise; creating/changing and reviewing SOPs related to the project. He/she will work closely with QA department to ensure lab compliance under GMP regulation in timely manner. He/She will be creating and maintaining logbooks, updating SOP books, scanning and archiving the GMP documents, updating data tracking sheets, maintaining calibration schedule for all equipment, performing lab safety and hazardous waste inspection on regular basis. In addition, he/she will be ordering chemicals, reagents, equipment, maintaining inventories and supporting shipment of material.
Experience working in QC lab/GMP environment is preferred. Candidates coming from research environment must have prior experience with QC/GMP requirements.
Candidate must have:
- Excellent orientation to details
- Excellent organization skills (for scanning and archiving the GMP documents, updating data tracking sheets, maintaining calibration schedule for all equipment etc.)
- Knowledge of TrackWise deviation system
- Ability to communicate clearly across organization (within multiple departments QA, QC, metrology)
- Ability to handle well stress and very tight timelines
- Enjoyment working on documentation/paperwork
- Working experience with high throughput sample processing/analysis
- Working experience in a biochemical, analytical or clinical labs
Excellent written and oral communication is critical
BS or MS