At Minaris Regenerative Medicine our vision is creating future cell therapy miracles together. We are a leading global contract development and manufacturing organization dedicated to the advancement of cell and gene therapy products. We believe in the transformative potential of cell and gene therapies and we are shaping the future of medicine. We open doors in the regenerative medicine industry for those looking to transform medicine while continuously improving an innovative, growing company.
Conducts investigations, including but not limited to deviations, environmental excursions, non-conformances, discrepancies, etc. to improve the processes by implementing corrective and preventive actions (CAPAs) to ensure compliance. This position is regular, full-time and exempt.
Essential Functions And 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.
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.
Minimum Required Training
GMP Training
Quality Systems Training (Change Control, Deviation/CAPA)
Minimum Required Training
Supervisory Responsibilities
This job has no supervisory responsibilities.
Working Environment
May occasionally work with sealed-packaged blood bags and are expected to utilize universal precautions with all human specimens, though breaching the bag is not expected. 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.
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.
Physical Requirements
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.
Disclaimer
The above information in this description is intended to describe the general nature and level of work performed. It does not contain nor is it intended to be interpreted as a comprehensive inventory of all duties, responsibilities and qualifications required of employees assigned to this job. Duties, responsibilities, and activities may change at any time with or without notice.
TBD