- The Production Support Specialist works closely with Operations and Quality Assurance, ensuring that the appropriate support is provided for all batch records and logbooks are performed and reviewed according to corporate and site procedures and guidelines
- The incumbent is also responsible for performing data entry and trending of critical/key process parameters
- Provide production support to Supervision
- Perform review of Production Batch Records for assigned department and post sign to get corrections if needed from all personnel on the applicable shifts
- Ensure corrections are made according to applicable procedures
- Review logbooks associated with cleaning, steaming and use of production equipment or areas
- Answer questions throughout the day from QA, QC, Investigators, Shop Floor Personnel and Supervisors, Technology, Process Improvement, DOC Management
- Perform training as required
- Enter LIMS Meta Data (Non-Batch Related Data)
- Pick up Production Batch records from QARM representatives
- Prepare the PBR record for the next day (forms, dots, labels etc.)
- Transport records between Operations and QA and vice versa
- Data Entry for Manufacturing Data Trending Systems, such as MIND/ DART
- BS Degree with 0-3 years Manufacturing, Quality, Technology or related experience
- Proficient written/oral/analytical skills
- Attention to detail and working knowledge of cGMPs
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