Job description – Supervisor, QC Operations

This position will function in a leadership role to supervise core responsibilities for QC Operations. The QC Operations Supervisor will lead activities related to technical writing, stability programs, document review, and QC lot release. This position will provide oversight to auxiliary QC functions requiring strong organization skills and attention to detail. Interactions will be extensive within the company and extend to external clients and collaboration partners. Maintaining a conscientious team work approach to achieve QC and company objectives is critical.

 

ESSENTIAL DUTIES AND RESPONSIBILITIES:

  • Oversight of QC data management, metrics, and trending
  • Oversight of the document review process to ensure adherence to regulatory standards and company objectives
  • Stability programs for multiple clients including scheduling and report generation
  • Review of documents such as out-of-specification investigations, non-conformance investigations, and technical reports.
  • Review training status of QC Operations to ensure that all training is current
  • Performs regular audits of QC SOPs, documentation, and lab environments for compliance with GMP and GDP
  • Use of the internal management system to guide objectives and to set goals for QC Operations

 

OTHER KNOWLEDGE AND SKILLS REQUIRED:

  • Good organizational skills, strong attention to detail, and the ability to work within a fast-paced environment
  • Strong math skills and knowledge of life sciences
  • Demonstrated initiative for continuous improvement
  • Experience with root cause analysis, conducting lab investigations, and technical writing
  • Strong capability for logical, analytical, and strategic thinking
  • Problem analysis and resolution skills required
  • Excellent Excel, PowerPoint and MS Project skills
  • Excellent communication and interpersonal skills are must
  • Must be able to manage multiple complex projects
  • Demonstrated ability to work well with others in a multicultural environment

 

EDUCATION AND/OR WORK EXPERIENCE REQUIREMENTS:

  • BS in a life science
  • Minimum of 2 years experience in a leadership role.
  • Experience working in a GMP/ laboratory / Manufacturing environment required.
  • Experience working in a contract manufacturing/development environment preferred.
  • Knowledge of biotech or cellular manufacturing industry is preferred

 

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