Compliance Specialist Malvern, PA Duties : -The Compliance Specialist supports the maintenance of all Good Manufacturing Practice / European Union documentation related to the packaging of clinical investigational product, the maintenance and distribution control of master batch records, protocol specific product information files, production batch records, entering / updating / distribution of standard operating procedures, lesson plans, training records, updating / distribution of HSE risk assessments, completed batch documentation history, updating the packaging Master Study Schedule and man-
days for each study, enters and ensures accuracy of the data within the production planning / scheduling tools for Packaging Operations, and Clinical Packaging Operations archives.
Requirements : -Bachelor’s degree in an Administrative or Business discipline -Minimum of 2 years’ experience in handling planning, training, batch record, and SOP documentation in a GMP / EU regulated environment.
Experience using planning software (i.e., Microsoft Project, OPX2, Optime) is required. -Certification in Information / Documentation management or planning or equivalent experience.
Experience supporting or in auditing departmental documentation. -Certification / training in GMPs / EU regulations. About Tech USA : Tech USA, Scientific Solutions is a comprehensive provider of staffing and workforce solutions throughout the Scientific Industry, including Biotechnology, Pharmaceutical, Clinical Research, Healthcare, Biodefense, Environmental, Chemical and Food Sciences.
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