Quality Assurance Specialist
ABOUT ARCELLX: Arcellx is a venture-backed, early-stage biotech company focused on the development of novel cell-based cancer therapies. The company is located in Gaithersburg, Maryland and has assembled a team of biotechnology professionals with expertise in biologics discovery, characterization, and development. Lead products will incorporate proprietary technologies that enhance tumor-specific killing by genetically engineered human immune cells.
Quality Assurance specialist position is responsible for performing quality functions such as implementing and monitoring the GMP related activities to ensure they are incompliance with Arcellx's the Quality Management System (QMS) and Regulatory Agency (FDA) requirements. The candidate shall have good knowledge and understanding of the relevant GMP regulations and shall have the required working experience in a GMP manufacturing environment. The candidate shall be a result-oriented self-starter with good communication skills and a commitment to teamwork and reliability.
The main responsibilities will include but are not limited to:
- Preparing/authoring and implementing quality assurance policies and procedures.
- Ensuring that the GMP activities are in compliance with the Arcellx's QMS and Regulatory requirements by performing internal audited and implementing and evaluating the CAPA program.
- Conduct reviews of Quality documents and records e.g. SOPs, Batch Record, Quality Control documents and test data, validation protocols and reports, lab notebooks etc.
- Perform lot disposition function.
- Perform Vendor audits and evaluate CAPA plans as required.
- Perform QA on the floor activity.
- Represent Quality during investigation of deviations, OOS, quality incidences etc. and evaluate CAPA plans. Approve related documents and reports.
- Deliver Quality Management Systems (QMS) training for employees such as, New Hire Orientation Training, Good Documentation Practices, Investigation of Quality events, etc.
- Any other duties and function related to maintenance of QMS as required by the management.
- BS in the life sciences e.g. Biochemistry, Chemistry, Chemical Engineering, Biology, related field.
- Minimum 4-6 years of hands-on experience in performing GMP quality compliance functions.
- Ability to apply scientific and regulatory principles utilized to solve operational, as well as routine quality tasks.
- Must have strong organizational skills and an ability to handle track and execute multiple priorities
- Highly motivated, with willingness to acquire new skills and ability to learn quickly
- Strong engineering/scientific understanding, and ability to apply knowledge to process development
- Detail oriented, good documentation practices, technical writing and verbal communication skills
- Possess strong problem solving and analytical skills and be an independent and creative thinker
- Ability to navigate and be successful in a fast-paced, highly matrixed work environment.
- Interpersonal and leadership skills to work with teams in different functions and organizations
Without exception, applicants must submit both a cover letter and resume to be considered for these positions and must have experience in one of the fields listed above.