Our Biotechnology client specializing in Cell and Gene Therapy is recruiting for a  Compliance Investigator, Manufacturing who will lead life-cycle investigations, including but not limited to deviations, environmental excursions, non-conformances, discrepancies, etc. to improve the processes by implementing corrective and preventative actions to ensure compliance.

• 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.

 REQUIREMENTS

• 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.

Working Environment

While performing the duties of this job, the employee may occasionally be exposed to infectious diseases transmittable through human blood, tissues, or bodily fluids and are expected to utilize universal precautions with all human specimens.

Please note this job description is not designed to cover or contain a comprehensive listing of activities, duties, or responsibilities that are required of the employee for this job. Duties, responsibilities, and activities may change at any time with or without notice.

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