Job Description
Duties & Responsibilities:
- To perform this job successfully, an individual must be able to perform each essential duty satisfactorily.
- The requirements listed below are representative of basic knowledge, skills, and or abilities required.
- Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
- Responsible for the manufacture of bulk clinical and commercial kit reagents.
- Responsible for sub-assembly formulation.
- Prepares and or processes raw materials.
- Performs QC testing of reagents, component formulations and some in-process testing.
- Participates in transfer, support activities and continuous improvement on existing processes.
- Maintains detailed device history records and training logs.
- Ensures proper transportation, handling, and disposal of hazardous, bio-hazardous and or infections substances.
- Operates and calibrates all general lab equipment.
- Completes ERP transactions.
- Maintains measures and dispenses materials.
- Operates CIP and or autoclave systems.
Preferred Qualifications:
- GMP manufacturing experience.
- Production chemistry experience.
- Reagent manufacturing experience.
- Laboratory experience.
- Experience completing batch records and controlled documentation.
- ERP transaction experience.
- Lean Manufacturing knowledge .