Senior Quality Associate
A2 Biotherapeutics, United States
Job Description
At A2, our mission is to extend the reach of cell therapy to tackle the next frontier in cancer treatment: solid tumors. Our team is dedicated to pushing the boundaries of science to transform medicine and turn the tide on serious illness. Central to achieving this mission is our focus on recruiting the best talent and building an environment that enables our team to do the best work of their careers and make an impact on patients and society at large.
We are seeking a highly motivated Senior Quality Associate to join our team reporting to the Senior Manager, Quality. In this role, you will execute work plans and cross-functional team projects to operate the phase appropriate Quality Management System (QMS), enabling clinical investigational cell therapy manufacturing at our Agoura Hills California site. You will be responsible for identifying opportunities for improvement and implementing solutions that advance the quality operations/quality systems in clinical manufacturing.
This position requires demonstrated Quality compliance experience and operational capabilities to drive objectives that ultimately contribute to our mission of changing cancer patients' lives. If you are looking to join a fun, fast paced amp; growing team in a cell therapy/tech ops environmentapply today!
Responsibilities:
- Working within A2 Quality standard operating procedures (SOP) and policies, execute assigned responsibilities in the Quality Operations unit in the A2 clinical manufacturing site. This includes, but is not limited to: batch record review, product release, change control, and quality support on the manufacturing floor.
- Under management direction, implement phase appropriate Quality Systems to enable FIH (First in Human) clinical manufacturing.
- Execute assigned quality support, in a team environment, for clinical product(s) tech transfer from Process Development to Manufacturing functions.
- Train and mentor on Quality standards, as directed.
- Conduct work according to environmental health and safety guidelines.
- Document and perform quality investigations, as needed, to ensure continuous improvement in product/process quality.
- Support GMP auditing of internal functions, and external services/suppliers, as directed.
- Write technical documentation including SOPs, quality assurance electronic records, and summary reports. Revise/update accordingly to implement continuous improvement solutions.
- Support the preparation of data packages for regulatory agencies and/or presentation, as assigned.
- Work cross-functionally with Manufacturing, Process Development, Facilities/Engineering, and Supply Chain to execute on assigned tasks to meet corporate goals.
Requirements
Basic Qualifications
- Bachelor's degree in natural sciences or related discipline and 5+ years of biotechnology or biopharmaceutical experience in clinical/commercial operations. Of which more than 1 year must be in cell/gene therapy products.
- OR Associate’s degree in natural sciences or equivalent and 10+ years of biotechnology or biopharmaceutical experience in clinical/commercial operations. Of which more than 1 year must be in cell/gene therapy products.
- AND must have operational knowledge of applicable GMP requirements for drug/biologics manufacturing.
Preferred Qualifications:
- Ability to contribute to the design and implementation of phase appropriate quality operations and systems meeting FDA requirements, in cell/gene therapy manufacturing.
- Ability to use operational experience and company procedures to resolve operational problems and challenges.
- Proven track record of quality decision making in issue resolution, collaborative teamwork to meet manufacturing/site KPIs, and quality systems development.
- Highly motivated, proactive and enthusiastic team player who builds strong relationships with colleagues and partners.
- Ability to work with minimum supervision, collaborate cross-functionally, and utilize resources efficiently.
- Excellent organizational, interpersonal, verbal and written communication skills.
Benefits
At A2 we believe in investing in our team. Our compensation amp; benefits programs are just one of the many ways we strive to help our employees take care of themselves and their families. We offer a variety of programs, from comprehensive medical insurance to generous time off policies designed to help meet the needs of our diverse team.
Compensation and benefits include:
- Competitive base salary and annual incentive opportunities
- Equity participation
- Comprehensive health and welfare benefits (including medical, dental, vision, life, disability, and accident insurance)
- Wellness and