QA Support Specialist

1 month ago

Gaithersburg, United States Cartesian Therapeutics Full time

**Summary**:
The QA Support Specialist reporting to the Senior Director, QA will support process development and manufacturing activities such as change control, deviation management, corrective and preventative action and overseeing environmental monitoring. This person will need to be comfortable with technology, software, automated equipment, instruments, facility operations, someone comfortable in a production environment.

**Principal **Duties/Responsibilities**:

- Quality assurance operations in support of process development and early clinical manufacturing activities, such as:

- Assist in implementing and maintaining the quality systems programs including but not limited to:

- Overseeing environment monitoring
- Preventative maintenance and calibration
- Deviation management
- Change control
- Corrective and preventative action
- Material controls/material management
- Conduct batch record review for clinical and commercial product manufactured
- Maintain approved labeling materials and process/distribute per company procedures
- Under limited direction and supervision, create, review, and revise standard operating procedures
- Support and contribute to quality improvement initiatives
- Participate in team meetings and make recommendations related to changes in processes, process improvements and provide suggestions as needed
- Assist in the internal audits as required
- Other duties, as assigned

**Qualifications**:

- Bachelor's degree, required
- Minimum 3-5 years of relevant pharmaceutical, biotechnology or medical device industry experience
- Background in one or more specialties of biotechnology: bioprocess, cell technology, biomedical engineering, cell therapy, tissue engineering, regenerative medicine, process development, cell biology, chemical engineering, and/or biochemical engineering
- Experience executing validations plans and reviewing validation protocols, reports and technical documents.
- Process Excellence training, preferred
- ASQ certification, preferred
- Familiarity with inspection methods and techniques, preferred
- Knowledge and experience with standard bioprocessing skills as well as use and maintenance of common laboratory procedures and equipment, preferred
- May be required to work evenings, off-hours, holidays or extended periods of time
- Will spend a portion of time in clean room environment to provide oversight to manufacturing operations and will be required to meet applicable gowning and personal protective equipment guidelines

**Work **Environment**:
The position requires hands-on work setting up and operating equipment in R&D and manufacturing environments. An employee in this position works in an environment in which safety, environmental and health concerns may demand constant attention. Strict adherence to Cartesian's policies, rules and regulations is required. While performing the duties of this job, the employee handles hazardous chemicals in the laboratory. The employee will be required to wear all appropriate safety equipment including but not limited to eye protection, gloves, shoes, and lab coat. Position may require extended periods of standing.

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