1. Releasing product
- Performs laboratory analysis on products for the purpose of:
2. Assessing stability
3. Facilitating complaint investigation
4. Effecting raw material release
5. Facilitating value assignments
6. Supporting Advanced Manufacturing and other technical service groups
- Prepares samples for testing and tests and releases product in accordance with written test procedures.
- Schedules testing to meet department and plant commitments.
- Troubleshoots test procedures and/or equipment when problems arise.
- Evaluates analytical results and determines conformance to specification; must be able to detect deviations and out of specifications events.
- Maintains instrumentation/equipment in accordance with manufacturer’s labeling and in-house audit and calibration procedures.
- Maintains records and logs in accordance with procedures and GMP.
- Assists in training laboratory personnel on lab procedures and operations of instrumentation/equipment.
- Maintains working laboratory inventory.
- Other laboratory functions as deemed necessary to support the business needs of the company.
- Associates degree in Biology and/or Chemistry or two years of college level courses with emphasis on science and one year of lab experience, or three years laboratory experience. Required area of experience in Analytical chemistry, Immunoassay, Hematology, Microbiology, Coagulation, Histology, Cytology and Clinical Chemistry.
Non-Negotiable Hiring Criteria:
- Normal laboratory environment. Handles blood products and other biological and chemical hazards. Position may require frequent communication and walking to other areas in which designated PPE will be required. Position will require sitting and standing. Additional PPE will be required when working with potentially infectious material or chemical hazards. Employee may occasionally lift and/or move up to 45 pounds.
- Proficiency in one or more of the following: Analytical Chemistry, Immunoassay, Hematology, Microbiology, Coagulation, Histology, Cytology, and Clinical Chemistry.
- Ability to organize work effectively to meet scheduling commitments.
- Ability to troubleshoot problems with limited assistance.
- Ability to interact with all departments and occasional contact with outside sources
- Knowledge of GMP and ISO requirements
- Microsoft Office (Word and Excel) required.
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