Quality Lab Associate I

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

Physical Requirements
Must be able to physically perform all assigned activities.

Required Education and Experience
B.S. Degree in Science (Microbiology, Biology, Chemistry or other life science degree with Microbiology or Biology, preferred)
Microbiological analysis or equivalent lab experience within coursework
Experience within a quality system, preferred
1-3 Years experience

Other Duties as Assigned
Please note this job description is not designed to cover or contain a comprehensive listing of activities, duties or responsibilities required of the employee for this job. Duties, responsibilities, and activities may change at any time with or without notice. Overtime is worked as required.