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This is where your creativity addresses challenges. You are creative, thorough, and a heads-down do-er. You embrace a challenge and truly apply the collaborative powers of your team to produce great results. You are motivated by work that is never the same from one day to the next. As a Quality Laboratory Technician- Particulate Matter, you are unafraid of navigating through vital internal processes to facilitate a product you deeply believe in. You can absorb and act on sophisticated procedures and data and train your team or peers if needed. You take pride in getting things done quickly without sacrificing safety or quality.
Job Responsibility
Collect supplemental PM samples throughout the facility following Standard Operating Procedures on a defined frequency
Conduct testing of products in compliance with USP <1790> and USP <788> methodology
Adhere to aseptic techniques to maintain the integrity of samples and prevent contamination
Visually inspect filters for presence of particulate matter size 150 microns or higher
Prepare and calibrate testing equipment and solutions per standard operating procedures
Troubleshoot, raise, and resolve issues related to testing procedures or equipment
Collaborate with other quality team members to ensure samples are collected, delivered, tested, and released within defined timeframes
Promptly communicate issues with testing or inspection testing, including out of limits
Collaborate with internal investigators to troubleshoot testing process in the event of product out of limits
Participate in internal and external audits / inspections
Requirements
Minimum of High School Diploma or GED
2+ years of experience with aseptic technique requirements such as laboratory or manufacturing related area
Strong understanding of quality principles and Good Manufacturing Practice, including Good Documentation Practice
Excellent attention to detail and ability to focus on repetitive tasks
Digital literacy including knowledge of Microsoft office applications (Word, Excel)
Must have good social skills and able to work reliably and efficiently in a team-based environment in small spaces
Able to lead multiple tasks/priorities in a timely manner
Able to work independently and lead time to complete assigned tasks
Schedule flexibility on occasion to ensure testing is performed in defined timeframes
Be able to perform testing using aseptic techniques, often requiring manual dexterity
Be able to lift 10 - 20 pounds routinely
Be able to pass inspector qualification requirements for visual inspection