QC Analyst Requirements: -Min. BS/BA Biology, Chemistry, or Medical Technology - 3-6 months of research experience (could be academic, internship, co-op) or industry experience Roles and responsibilities:
- Performs analyses of Clinical Chemistry, Critical Care, coagulation and microbiology controls and reagents using various automated techniques in accordance with established quality standards and GMP requirements
- Perform automated and manual assays as detailed in departmental/plant SOPs and QC Monographs including raw material, in-process and finished product
- Interprets test results against specifications and decides if assays pass or fail
- Maintains documentation of all work performed in accordance with GMP requirements
- Performs product stability, proficiency, environmental testing and water system testing
- Responsible for routine preventive maintenance, general trouble shooting, general cleanliness and calibration of lab equipment
- Updates departmental SOP's and QC Monographs as directed
- Performs microbial testing per SOP's and QC Monographs
As well as below:
- Orders required laboratory supplies, reagents and other consumables
- Monitors proper storage conditions and expiration dates
- Disposal of hazardous and bio-hazardous materials
- Maintains retain samples in accordance with established procedures
- Maintains statistical process control charts and other tracking reports