Manufacturing Specialist
57 East Willow Street Millburn, NJ 07041 US
Job Description
Scope: Prepare/modify the production activity schedule, according to the general production planning
- Organize shifts allocating people and equipment taking in to account all applicable HSE, GMP laws and other constraints
- Ensure all production activities are being performed compliantly
- Liaise with other departments, supply chain, QA, QC, engineering, for organizing production activities and to troubleshoot issues involving manufacturing
- Interact with production personnel for planning production and non-production activities such as training and addressing questions from operators
- Lead/facilitate weekly production meetings
- Perform other activities as assigned by the Production head/manager
- Operates in full compliance with GMP, HSE and other applicable laws
- Perform batch record review and input in process data in real time
- Review cleaning documentation and address any GDP issues
- Track and ensure batch record corrections are performed and reviewed within the required time frame
- Support change control activities and edit documents as needed
- Required to gown with proper PPE in a Grade C environment and work in an area with radioactive materials
- Perform production system verification checks for batches on the production line
- Assist with implementation of process improvements
Education: BSc in Life Sciences and/or related work experience (pharmaceutical manufacturing)
Languages: English
Experience / Professional requirements:
- 3-5 years of related experience in cGMP/FDA regulated industry
- Ability to collaborate with other groups, teams and departments in addressing production, production, and quality assurance-related issues
- Strong interpersonal, written, communication skills along with problem solving and follow-up skills are required
- Must be well organized, flexible and work with minimal supervision
- Ability to lead through influence
- Strong sense of ownership and accountability
- Ability to adapt and learn new systems
- Demonstrate a high level of discipline and self-motivation
- Provides innovative solutions to complex or process improvement issues
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