Responsible for maintenance of the Carmell Therapeutics Quality Management System (QMS) and support the development of new products and manufacturing activities,
This individual will work closely with internal and external resources utilizing various quality engineering and manufacturing tools in the development and manufacture of innovative new products.
Main Job Tasks and Responsibilities
- Work directly with the R&D and Manufacturing team to support production activities, including review and verification of Master Batch Records, in-process and final release testing
- Contribute to the following Quality systems:
- Corrective and Preventative Action
- Nonconformance Reporting
- Out-of-Specification (OOS)
- Supplier Management
- Production and Process Controls
- Document Control
- Actively participate in all aspects of design control, process validation, material sourcing, and supplier management.
- Responsible for quality planning, risk management, sterilization, and packaging/stability study activities
- Utilize standard statistical analysis techniques to determine product acceptance, evaluate process capabilities, and develop statistically sound tolerance limits based on product specification and associated product risks
- Interface with suppliers to assure quality and reliability of the design during transfer to manufacturing as well as overseeing and support of quality issues at the supplier’s site
- Perform supplier site audits and work with suppliers to improve quality of applicable services
- Responsible for environmental monitoring program
- Provides technical guidance and training to other team members
- Manage and update modules in electronic documentation system
- Maintain and schedule equipment calibrations and Preventive Maintenance (PM) activities.
- Assign training requirements for all employees.
- Assist manufacturing in a quality capacity, as needed
- Assist with internal audit program, as needed
Education and Experience
- Bachelor's degree in Engineering, Life Science, Physical Science or a related field is required. Experience
- A minimum of 3+ years of Quality Assurance and/or Manufacturing Engineering experience is required. Experience in the medical device, pharmaceutical, biologics or other highly regulated industry is required.
- New product development experience preferred
- Experience with the development of chemical, biologic, and medical device products a plus.
- Knowledge of ISO 13485, cGMP, 21 CFR 11, 820, 211, 600’s
- Familiarity with cleanroom standards and best practices
- Technical writing experience is a plus
- Candidate must be able to communicate effectively at all levels of the organization
- Experience with startup company preferred
- Proven track record of working in a team environment and autonomously
- Partnering and teamwork
- Ability to work with little oversight
- Attention to detail
- Planning and organizing
- Data collection, management and analysis
- Excellent communication skills, both verbal and written
- Team oriented and personally committed to continuous improvement
- Demonstrated ability to interface effectively and positively with all members of the organization, suppliers and customers
- Computer literacy for basic Microsoft Office applications
- Ability to manage multiple duties and tasks
- Ability to lift or move up to 50 pounds
- Ability to sit/stand for 8 hours a day