Job DescriptionBusiness: Critical CareDepartment: Quality ControlLocation: BethlehemTravel: NoneJob OverviewPerform routine activities support efficient functioning of the Quality Control laboratory. Key Stakeholders: Internal Quality Control, Regulatory Affairs, Packaging, Manufacturing, Quality Assurance, Supply Chain Key Stakeholders: External Patients Reporting Structure Reports to Associate Manager Quality Control Essential Qualifications High school diploma or GED required, associate's degree in a scientific field preferred Experience
- 0 to 3 years of experience in a GMP laboratory setting
- Strong communication skills
- Strong computer skills
- Excellent organizational skills
- Able to work independently
Key Roles/Responsibilities:
- Maintains laboratory supply inventory to ensure no laboratory downtime. This includes proper labeling of chemicals and reagents.
- Management of reference standards system
- Responsible for all ordering for the quality control department and subsequent receipt
- Preparation of documentation and chemicals for shipment to third-party laboratories and customers
- Sampling raw materials and packaging components upon receipt
- Organizing and storing samples in accordance with all safety and compliance requirements
- Organizing QC Lab documents including but not limited to the qualification, calibration, and validation documents
- Cleaning and maintaining laboratory workstations, equipment, and retain room
- Retain sample management
- Proper maintenance of GMP documentations of all applicable activity
- Calibration of instruments when necessary
- Gas cylinder change-outs
- Follow SOPs and maintain good documentation during work: data management and maintenance to ensure compliance for audit preparation
- Write data summary reports
- Work in strict GMP environment
- Support Lab with Continuous Improvement Projects