Responsible for testing all non-chemically defined components, and other raw materials as required, which are used in the production of Dehydrated Culture Media. Testing includes physical, chemical and microbiological analysis. Assist in duties assigned to the Media and Process Development Department, including product development, problem solving, special projects and committee work.
Develop new media products. Maintain project files. Perform technical writing for new products as required. Perform expiration studies on new products to establish shelf life. Organize and monitor clinical and in-house product evaluations. Maintain compliance procedures as assigned. Assist with Media and Process Development and Dehydrated Culture Media projects. Test non-chemically defined components to be used in the manufacture of DCM.
Advise MPD Sr. Supervisor or the Senior Manager, Manufactuirng Sciences of test results. Work with DCM Supervisor and DCM Production/Packaging Planner to assure adequate inventory levels of raw materials required to produce DCM. Write or modify raw material test specifications for DCM components. Raw material testing includes weighing, rehydrating, sterilizing, dispensing and microbiological testing of media. Retain retention and working samples, and records of all necessary raw materials, including receiving records, DCM and raw material test results. Implement testing of DCM blend samples and notify MPD Supervisor of any variation. Implement pretest and preparation of Quality Control sample. Maintain records of RPMI product line. Carry out all duties according to Standard Operating Procedures and current Food and Drug Administration Good Manufacturing Procedures. Implement testing of DCM out-date samples each year until one year past expiration. Submit out-date forms to the Sr. Supervisor MPD.
In addition, other duties may be assigned as the need arises.
EDUCATION, EXPERIENCE, ABILITIES
- Bachelor of Science in Microbiology or other biological or physical sciences.
- Knowledge of Micro Soft office, including Word, Excel, Outlook and PowerPoint
- 3-5 years of direct microbiology experience within the medical device industry preferred.
- Effective communication skills.
This position is not approved for relocation assistance.