Description:
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Assignment is dedicated to pyrogen testing. This testing is to expedite release of product to accommodate the fulfillment of orders that are currently in a backorder situation.
Job Responsibilities
- Perform Bacterial Endotoxin Testing and on intravenous solutions, sets, devices, raw materials, and plant water
- Use laboratory instrumentation, computer systems and software to collect and record data
- Must be able to use standard software applications such as MS Office Suite
- Perform analysis requiring Good Laboratory Practices and understanding of microbiological principles
- Perform investigations utilizing problem solving and troubleshooting
- Prepare and perform protocols
- Investigate deviations and ability to write exception documents
- Ensure regulatory compliance
- Learn, understand and apply rigorous quality standards utilizing Standard Operating Procedures (SOPs) within a quality system
- Complete and peer-review documentation
- Complete all testing, including special projects / protocol testing in a timely and appropriate manner
- Must perform all other duties and responsibilities as determined by supervision/management
- Must have knowledge of both plant and department environmental health and safety regulations and comply with said regulations accordingly
- Must be able to work off shift hours and some weekends
- Must notify the supervisor and take appropriate action if any safety, quality, mechanical or discrepancy issues occur
- Must sustain a clean and safe work area using 6S principles
Knowledge, Skill and Abilities
- Computer competency, required
- Ability to work independently
- Good organizational and time management skills
- Good oral and written communication skills.
- Ability to handle multiple priorities in a fast-paced environment
- Prior experience with Bacterial Endotoxin testing