- Determine the causes and preventative actions of Deviations, Non-Conformances, OOS, OOT, field complaints and environmental excursion investigations.
- Drive investigations to true root cause using appropriate investigation tools.
- Benchmark industry standards to develop, advocate, and implement investigative and impact assessment tool sets.
- Define and implement effective preventative actions to prevent recurrence.
- Manage multiple investigations in different stages of the process to efficiently meet compliance deadlines and product release dates.
- Collaborate with cross-functional teams to develop and track CAPA plans.
- Identify and create appropriate trending rules that trigger corrective actions.
- Analyze process data and evaluate trends to identify major improvement opportunities.
- Effectively utilize change management approach.
- Develop materials to train and educate personnel on writing problem statements and use of root cause analysis tools, discrepancy and deviation process.
- Champion CAPA plans and implementation.
- Provide communication plan for on-going deviations & CAPA's.
- Effectively create and communicate CAPA plan to responsible parties.
- Oversee timely completion of deviations, CAPAs, and Change Controls as necessary.
- Ability to abide by quality standards.
- BS degree in a Quality/ Process related field.
- Experience in GMP Operations and/or Quality Assurance in Cell Therapies, Biotechnology or Bio-Pharma.
- Root cause analysis experience in pharmaceutical or FDA regulated operation preferred.
- Experience using e-Quality Management Systems preferred.
- Relevant IT skills (able to work with Visio, Microsoft Project and Excel)
- Ability to think strategically and tactically (detail-oriented)
- Strong collaborative and influencing skills and ability to work well in a cross-functional, matrixed environment
- Analytical and problem-solving skills
- Strong written and oral communication skills
- Flexible and able to adapt to company growth and evolving responsibilities
- Integrity, accountability and strong dedication to regulatory compliance
- Continuous improvement mindset
- Ability to work effectively as a team and independently.
- Quality Systems Training (Deviation/CAPA)
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