Manufacturing Specialist

21 hours ago


Reston, Virginia, United States Anika Full time

Job Summary:

Anika is seeking a highly skilled Manufacturing Specialist to join our team. As a key member of our operations team, you will be responsible for delivering operational excellence and skill-based training on and off the production floor.

Key Responsibilities:

  • Operational Excellence: Partner with manufacturing supervisors to perform on-time reviews of batch records and exception documents, ensuring compliance with regulatory requirements.
  • Training and Development: Develop and deliver training programs for Gel manufacturing operators, focusing on skill development and operational excellence.
  • Process Improvement: Collaborate with operations management to implement Lean manufacturing concepts, driving efficiencies and eliminating waste.
  • Material Management: Oversee the ordering and tracking of Gel manufacturing expensed materials through the use of a Kan Ban system.
  • Quality Assurance: Review completed Gel production batch records and documentation prior to submission to quality assurance.
  • Leadership: Act as a subject matter expert for major processes within Gel manufacturing departments, providing guidance and support to junior staff.
  • Documentation: Revise and author standard operating procedures, batch records, and work instructions to optimize usability and compliance.
  • Change Management: Assist supervisor/engineer/facilities with initiation of Change Controls, CAPAs, deviations, or investigations of various complexities.
  • Inspection Readiness: Participate in inspection readiness and inspection support activities, performing data mining when required.

Requirements:

  • Education: Bachelor's degree in Chemistry or Chemical Engineering or equivalent experience.
  • Experience: 6-8+ years' experience in cGMP manufacturing with High School Diploma or equivalency or Bachelor's degree in Chemistry or Chemical Engineering or relevant experience or related field or previous relevant experience.
  • Leadership Experience: 2+ years leading teams/personnel in cGMP environment.
  • Technical Skills: Experience working with technical leadership on projects, basic knowledge of Microsoft Word, Excel, and PowerPoint, and ability to perform computer-based real-time ERP transactions and material ordering.
  • Soft Skills: Excellent verbal and written communication skills, excellent organizational/tracking skills and attention to detail, ability to prioritize tasks and escalate when appropriate, and ability to work flexible hours to complete work activities.

Desired Qualifications:

  • Experience working in a clean room or using aseptic technique.
  • Experience using and troubleshooting commercial-scale automated equipment.
  • Experience performing in and leading a result-driven, team environment.
  • Experience performing ERP transactions using SAP and maintaining spreadsheets.


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