Responsibilities:

\nOperate in a controlled GMP environment.\nPerform routine procedures following written instructions (SOPs, batch records, solution documents, protocols, etc.).\nEnsure compliance with established internal and external control procedures.\nParticipates in the execution of Drug Product activities to support the production/manufacturing schedule.\nDemonstrates operational proficiency in Drug Product-related process equipment, as required per business needs.\nInitiate and supports the closure of Deviation Reports.\nSupports the initiation and closure of CAPA and CR Tasks as required per business needs.\nReview in-process and completed documents for accuracy and to make sure batch records are turned in to area management within specified days of completion.\nResponsible for revising and originating production records, standard operating procedures, protocols and reports.\nSupports the ongoing continuous improvement within the Drug Manufacturing Process.\nMay collaborate with process science teams, analytical testing personnel, microbiological support team, facilities and sanitization groups in support of Quality Record investigations/closure.\n

Requirements:

Required:

0-3 years of experience with pharmaceutical or biotechnology manufacturing processes; or equivalent education, training, and experience.\n

Preferred:

\nHands-on skills with Aseptic technique, cleanroom gowning and extensive knowledge of Good Manufacturing Practices (GMPs).\nHands-on skills with aseptic fill finish operation. Hands-on experience with automated filling/capping machine, and Lyophilizer.\n

COMPETENCIES

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