Quality Lab Associate I

Job Description

Job 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.

Duties and 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.

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.

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.