Boston Metro Area, Massachusetts
- QC Associate
BS or MS in Biochemistry, Biology, Chemistry or related
- Provide support under GMP compliance.
- Involved in testing of quality control samples, HTS and QC stability testing using enzyme activity assays on dried blood spots following approved SOPs.
- Responsible to initiate/investigate and closing deviations in TrackWise; creating/changing and reviewing SOPs related to the project.
- work closely with QA department to ensure lab compliance under GMP regulation in timely
- 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)
- Working experience with high throughput sample processing/analysis
- Working experience in a biochemical, analytical or clinical labs
- Excellent written and oral communication is critical