Reporting to the NIS Director of Quality, the Scientist, Quality Assurance will support all Quality/GMP activities at NIS, as well as providing backup cover for the Director of Quality NIS is providing GMP testing to pharmaceutical companies. The ideal candidate will be familiar with the workings of a QC Laboratory. The job holder will contribute to the development, execution, and continued optimization of NIS’s Quality Assurance guidelines and procedures, which will underpin the validation of the facility’s various software systems and their ongoing connectivity. The role is key to ensuring the compliance of the facility’s quality, manufacturing, and engineering systems with current GxP and GAMP5 requirements.
- 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 cryo-TEM methods and analytical results.
- Other duties as assigned to support the business.
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.
Reports to: Director of Quality
Salary Range: $75,000 - $100,000
