Quality Assurance/Activities

5 months ago


New Haven, United States Katalyst HealthCares & Life Sciences Full time
Responsibilities and Requirements: Conduct and oversee quality activities to build out a clinical research site in New Haven, CT in adherence to relevant regulations and standards including as applicable;
(Good Clinical Practice), FDA and sponsor requirements. Specifically, ensure that clinical equipment is handled, supplies are inventoried and stored appropriately to meet such requirements. This includes equipment calibration, IQ, OQ, PQ as deemed necessary; and that the appropriate level of documentation is developed and fully established to record and support these activities. Identify the level of quality activities needed for clinical trial site equipment and supplies. Support scheduling for installation, calibration and qualification as appropriate to meet project timelines. Quality oversight and author, create policies/procedures/protocols/reports/plans as necessary to meet regulatory needs, work directly with client qualified personnel for execution. Creation of protocols and reports for equipment installation, qualification and calibration of required equipment according to manufacturer specifications and regulatory standards. Development of SOPs, training materials and all other related quality system document requirements not already established.

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