Quality Lab Associate I

Job Title: Quality Lab Associate I
Job Location: Cleveland, MS
Job Duration:12 Months+ (Possibilities of Extension)

Shift: Work shift – Std
 
Position Summary:
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.

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