Associate Compliance Investigator - Scientific

Job description

Title: Associate Compliance Investigator - Scientific

Location: Mountain View, CA

Job Duties/Responsibilities:

• Determine causes and develops preventative actions of Deviations, Non-Conformances, OOS, OOT, field complaints and environmental excursion investigations.
• Conduct investigations to true root cause using appropriate investigation tools. Benchmark industry standards to develop, advocate, and implement investigative and impact assessment tool sets. Implement effective preventive actions to prevent recurrence.
• Handle 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.
• Track and create appropriate trending rules that trigger corrective actions.
• 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 execute communication plan for CAPA s and on-going deviations to responsible parties.
• Conducts timely completion of deviations, CAPAs, and Change Controls as necessary. Ability to comply with quality standards.

Qualifications:

• Bachelor of Science in a Quality / Process related field Science/Engineering.
• Minimum of 3 years experience in GMP Operations and/or Quality Assurance in Cell Therapies, Biotechnology or Bio-Pharma.
• Knowledge of Root cause analysis in pharmaceutical or FDA regulated operation preferred.
• Working knowledge of cellular therapy and/or GMP procedures.
• Relevant IT skills able to work with Microsoft Word, PowerPoint, Visio, Project, and Excel.
• Experience using e-Quality Management Systems preferred.
• Minimum Required Training GMP Training Quality Systems Training Change Control, Deviation/CAPA Competencies/Candidate Profile.
• Strong collaborative and influencing skills and ability to work well in a cross-functional, matrixed environment and independently.
• 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.

For immediate consideration apply today!

Questions? Please reach out to Jessica Rubano at

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