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Manufacturing Specialist

Millburn, NJ 07041

Posted: 09/20/2023 Employment Type: Contract Job Category: Scientific Job Number: 576820 Is job remote?: No Country: United States

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
Payrate: $26.16 - $32.69 per hour
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