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Associate Compliance Investigator
2 months ago
At Minaris Regenerative Medicine, we are seeking a highly skilled Associate Compliance Investigator to join our team. As a key member of our quality assurance department, you will play a critical role in ensuring compliance with regulatory requirements and industry standards.
Key Responsibilities:- Conduct thorough investigations into deviations, non-conformances, and discrepancies to identify root causes and implement corrective actions.
- Develop and implement effective preventive actions to prevent recurrence of non-conformances.
- Collaborate with cross-functional teams to develop and track CAPA plans.
- Provide communication plans for ongoing deviations and CAPAs.
- Ensure compliance with quality standards and regulatory requirements.
- Bachelor of Science in a quality or 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 operations preferred.
- Working knowledge of cellular therapy and/or GMP procedures.
- Relevant IT skills (Microsoft Word, PowerPoint, Visio, Project, and Excel).
- Collaboration, accountability, adaptability, can-do, leadership, technical capacity, problem-solving, customer-centric, communication, project management, and presentation skills.
May occasionally work with sealed-packaged blood bags and are expected to utilize universal precautions with all human specimens. Other exposures may include gases (nitrogen), or corrosive chemicals (Clorox, potassium hydroxide), or exposure to liquid nitrogen. The noise level in the work environment is typical office noise level 70% of the time, and cleanroom noise level 30% of the time.
Must have the ability to work in a team-oriented environment. Must be able to work during the weekend, holidays, off shifts, and as required by the company. Must have the ability to work with specialized equipment. Must utilize proper personal protective equipment (PPE) when handling all human specimens, gases, corrosive chemicals, and liquid nitrogen.
Ability to work on ladders, work from heights, work in small crawl spaces, work outdoors in all weather conditions.
