Location: Winston Salem,NC, USA
Join us in developing pioneering therapies that aim to transform the treatment of CKD and change patients' lives. Our technology is designed to treat diseased kidneys using a patient's own cells and may prevent or delay dialysis or transplant.
* This is a 6-month contract role with the possibility of conversion to a permanent role depending on individual performance. This contract role does not include benefits or health insurance.*
Environmental Monitoring Analyst will participate in ProKidney's Environmental Monitoring Program supporting and maintaining a cGMP compliant facility. The EM Analyst will perform critical monitoring of in process operations performed by manufacturing along with routine monitoring of the GMP areas of the facility. Additionally, the EM Analyst will perform sample receipt and utility sample collection. In this role the EM Analyst will be responsible for continuous support of manufacturing operations on a 4/10 schedule working from 0600-1600 or 0800-1800 on SUN-WED or WED-SAT.
Responsibilities:
* Perform Routine Environmental Monitoring of the GMP areas.
* Perform Personnel Monitoring for Manufacturing Operations.
* Sets up and operates Environmental Monitoring equipment.
* Follows and executes Standard Operating Procedures, Work Instructions, and Protocols.
* Performs Reading, Revising, and Training on SOPs, WI, Forms, and Protocols.
* Support QC Micro Analyst in sample receipt from Manufacturing.
* Tracking and Trending of EM, Bioburden, Sterility, and Endotoxin data collected.
* Perform inventory stocking in the QC labs and request new materials from warehouse.
* Streaking and Isolation of recovered organisms
* Other Duties as assigned.
Education/Training: High School Diploma or greater
Experience: 0-3 years; previous experience in a GMP facility major plus.
Skills/Abilities:
* Ability to read and understand schedules.
* Ability to follow instruction and work on the go.
* Ability to work independently as well as in a team.
* Ability to understand importance of compliance.
* Strong Organizational Skills and attention to detail.
* Computer software skills including Microsoft Office (Excel, Word, Visio, etc)
* Ability to lift up to 30 pounds.
* Good hand/eye coordination
* Written and Oral Communication, team oriented, strong work ethic
ProKidney is an Equal Opportunity Employer. All applicants are considered for employment without attention to race, color, religion, sex, sexual orientation, gender identity, national origin, veteran or disability status. We are committed to the principles of equal employment opportunity for all employees with a work environment free of discrimination and harassment.