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Manufacturing Operations Specialist

2 months ago

Reston, Virginia, United States Anika Full time

Job Summary:

We are seeking a highly skilled Manufacturing Specialist to join our team at Anika. This individual will play a key role in delivering operational excellence and skill-based training on and off the production floor.

Key Responsibilities:

  • Partner with manufacturing supervisors to review batch records and exception documents in a timely manner.
  • Develop and deliver training programs for Gel manufacturing operators, ensuring they have the necessary skills to perform their duties effectively.
  • Work closely with Operations management to implement Lean manufacturing concepts, driving efficiencies and eliminating waste.
  • Oversee the ordering and tracking of Gel manufacturing expensed materials using a Kan Ban system.
  • Review and revise standard operating procedures, batch records, and work instructions to optimize usability and compliance.
  • Assist in the initiation of Change Controls, CAPAs, deviations, or investigations, and work with cross-functional departments to identify root causes.
  • Implement process resolutions and improvements on existing and future manufacturing processes.

Requirements:

  • Bachelor's degree in Chemistry or Chemical Engineering or equivalent experience.
  • Experience working with technical leadership on projects.
  • Basic knowledge of Microsoft Word, Excel, and PowerPoint.
  • Excellent verbal and written communication skills.
  • Ability to prioritize tasks and escalate when necessary.
  • Ability to work flexible hours to complete work activities.
  • Ability to wear personal protective equipment and work in a biotechnology/pharmaceutical manufacturing environment.

Preferred Qualifications:

  • 6-8+ years' experience in cGMP manufacturing.
  • 2+ years' experience leading teams/personnel in a cGMP environment.
  • Experience working in a clean room or using aseptic technique.
  • Experience using and troubleshooting commercial-scale automated equipment.
  • Experience performing ERP transactions using SAP and maintaining spreadsheets.