Regenerative Medicine Compliance Investigator

3 weeks ago

Mountain View, California, United States Minaris Regenerative Medicine Full time
Job Title: Associate Compliance Investigator

At Minaris Regenerative Medicine, we are shaping the future of medicine by advancing cell and gene therapy products. We are seeking a highly skilled Associate Compliance Investigator to join our team.

Job Summary

The Associate Compliance Investigator will conduct investigations, including deviations, environmental excursions, non-conformances, discrepancies, and other quality-related issues. This role will identify root causes, develop preventative actions, and implement corrective and preventive actions (CAPAs) to ensure compliance with regulatory requirements.

Key Responsibilities
  • Determine causes and develop preventative actions for 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.
Requirements
  • 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.
Competencies/Candidate Profile

Collaboration, accountability, adaptability, can-do, leadership, technical capacity, problem-solving, customer-centric, communication, project management, and presentation skills.

Quality Requirements

Build Quality into all aspects of your work by maintaining compliance to all quality requirements.

Ensure compliance to all FDA and Worldwide Quality & Compliance regulations (As applicable to the job function).

Attend all required Quality & Compliance training at the specified interval.

Working Environment

This role operates within a professional office environment of a manufacturing operations plant. This role routinely uses standard office equipment such as computers, phones, photocopiers, filing cabinets, and fax machines. Seating is mixed and includes open space seating, cubicle, and office space.

The physical demands described here represent those that must be met by an employee to perform the essential functions of the job successfully.

Ability to lift, transfer, or ship validation equipment or related accessories up to 30 pounds.

An individual may occasionally exert up to 30 pounds of force or a negligible amount of force frequently to lift, carry, push, pull, or otherwise move objects. Sedentary entails sitting most of the time but may involve walking or standing for brief periods.

Must be capable of moving, sitting, stretching, stooping, reaching with hands and arms, and have vision sufficient to read materials.

Must be capable of using hands and fingers to operate a computer and other office productivity machinery such as copy machine, printer, and calculator.

Must have the ability to communicate information and ideas so others will understand. Must be able to exchange accurate information in person, and on the telephone.

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