Senior Specialist, Investigative Operations and Excellence

2 weeks ago

Alameda, California, United States Enigma Search Full time

We are looking for a Senior Specialist, Investigative Operations and Excellence to join our team at Enigma Search, where you will spearhead Investigation Management and enhance Operational Excellence. This role is designed for a full-time, hybrid work environment.

Key Responsibilities: Investigation Management

  • Conduct thorough investigations into process deviations and laboratory issues, ensuring preventive measures are established to support manufacturing and quality control.
  • Draft comprehensive investigation reports that provide actionable recommendations for medium to high severity deviations.
  • Evaluate and synthesize information gathered during investigations, presenting trends and insights in detailed reports.
  • Effectively communicate findings and suggestions during team meetings.
  • Review batch records and logbooks to ensure compliance with current Good Manufacturing Practices (cGMP) standards.
  • Edit and update controlled documents (including batch records, SOPs, and test records) to maintain adherence to established procedures.
  • Monitor production workflows to gather essential data that supports investigations and assess the effectiveness of implemented changes.
  • Participate in or lead cross-functional teams to achieve objectives and contribute to investigations.
  • Collect, analyze, and trend process and analytical data to ensure consistency and timely responses.
  • Document training sessions and onboard new staff on investigative methodologies and practices.
  • Create and maintain investigation templates and tools to promote consistency and excellence in investigations.
  • Coordinate and lead meetings across various departments to facilitate collaboration.

Key Responsibilities: Operational Excellence and Continuous Improvement

  • Facilitate process enhancement initiatives (such as Lean/DMAIC projects and Kaizen events) with minimal supervision throughout all project phases: initiation, planning, execution, monitoring, and closure.
  • Deliver high-quality results on multiple projects concurrently by applying project management techniques, including clear project charters, timeline oversight, data analysis, and communication strategies.
  • Gather and analyze data to establish baselines, enabling root cause analysis, opportunity identification, solution development, and implementation.
  • Serve as a subject matter expert, mentoring all organizational levels in Operational Excellence principles and tools.
  • Collaborate with department leaders to define metrics that align with business goals, providing guidance on data collection and analysis.
  • Assist leadership in developing and maintaining an effective Daily Management System to connect with frontline operations.
  • Promote the vision of Operational Excellence and act as a change agent to foster a culture of continuous improvement throughout the organization.

Qualifications:

  • Bachelor's degree in Life Sciences, Engineering, or a related discipline.
  • Advanced degree (e.g., Master's, Ph.D.) is preferred.
  • A minimum of five years of relevant experience in Operational Excellence or continuous improvement, with at least three years in a dedicated role.
  • Experience in manufacturing, particularly within a Biopharmaceutical or Cell and Gene Therapy context.
  • Certification in Lean Six Sigma (Yellow Belt or higher).
  • Demonstrated ability to lead multiple initiatives from strategy to execution.
  • Proficient in implementing process improvement methodologies.
  • Strong skills in communication, interpersonal relations, influence, change management, and leadership.

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