Clinical Research Coordinator II – Cellular Manufacturing
with lab equipment lifecycle activities, including setup, qualification (IQ/OQ/PQ), calibration/verification, maintenance...
with lab equipment lifecycle activities, including setup, qualification (IQ/OQ/PQ), calibration/verification, maintenance...
, such as FAT, PQ etc. as well as other related activities Support and contribute to the preparation of the documentation package...
improvement projects Collaborate with R&D on OQ process validation planning and execution. Assume full ownership of PQ process...
equipment qualification and process validation (IQ/OQ/PQ). Perform Test Method Validation and Software Validation for hardware...
, including IQ/OQ/PQ/PPQ protocols and reports. Participate in PFMEA activities, time studies, and value stream mapping exercises...
/OQ/PQ activities (including commissioning activities of new equipment or areas). Develop scope for capital projects...
validations, OQ/PQ studies, design of experiments, transit testing, aging studies, sterilization validations, and ongoing process...
of process and equipment validation / qualifications (IQ, OQ, PQ). Assist in QA review and approval of software user acceptance...
(one of) CDI, Q, PQ or RI stamps . Support inventory accuracy goals through regular and accurate cycle counting . Support...
CDI, Q, PQ, or RI stamp . Maintain inventory accuracy through proper data entry and use of inventory management... to meet qualifications to obtain (one of) CDI, Q, PQ or RI stamps . Support inventory accuracy goals through regular...