KNOWLEDGE & SKILLS:

• Must be skilled in planning and organizing, decision-making, and building relationships.
• Must possess strong problem-solving capabilities and employ analytical thinking.
• Able to effectively work in a dynamic / fast-paced environment.
• Meets and exceeds all safety expectations and adheres to all NIS behaviors and values.
• Must have knowledge and experience with cGMP manufacturing, Quality, and Compliance.
• Must have knowledge on the review of deviation investigation and CAPA.
• Must have knowledge on how to perform Root Cause Investigation.
• Must be able to critically review investigations, interpret results and generate technical conclusions consistent with Quality risk management principles.
• Must have ability to work within a cross-functional team to complete investigations and resolve deviations. Ensures efficient and timely completion of deviations and CAPA closures.
• Proactively seeks to resolve deviations/investigation roadblocks impeding timely deviation and/or CAPA record closure.
• Must be able to effectively prepare communications to management with clarity and a high level of accuracy.
• Able to work independently and requires minimum direction to complete tasks; completes routine tasks as assigned.
• Confident in making decisions for minor issues.
• Contributes to goals within the work group.
• Excellent verbal and written communication skills.

BASIC REQUIREMENTS:

• Bachelor of Science in Physical Sciences, Engineering, related discipline. An equivalent combination of higher education and demonstrated experience will be considered.
• Minimum of 3 years’ experience in related cGMP environment: Cell Therapy, Pharmaceutical, Biologics, Medical Device operations.
• Minimum of 3 years in QA/QC.
• At least 1-2 years investigation experience.
  Job Type: Full-time
  Pay: $75,000.00 - $100,000.00 per year

Benefits:

• 401(k)
• Dental insurance
• Health insurance
• Paid time off
• Vision insurance

Work Location: In perso

RESPONSIBILITIES:

• Supports all activities for the Quality Operations Investigations group.
• Review and approve Site operational investigation.
• Review and approve Impact assessments or Product Quality Evaluation Approval.
• Review and Approve Corrective and Preventive Actions (CAPA Plan, Action approval, Effectiveness Check (EC) Plan, EC execution Approval).
• Participate in Audit and inspection including inspection readiness activities.
• Attend and participate at Investigation and CAPA Review Board.
• Review and approve Investigation Protocol/Plan and Summary report.
• Review and approve interim controls (Mitigation protocols) for continued production.
• Contribute to deviation management procedure improvement.
• Review and approve change requests and their implementation and closure
• Ensure appropriate CAPAs are generated to increase compliance and prevent repeat occurrences of deviations.
• Review and approve cryoTEM methods and analytical results.
• Other duties as assigned to support the business.