Quality Assurance Associate II - CAR T Production
City of Hope
Duarte, CA
ID: 7245908 (Ref.No. 10026230)
Posted: May 20, 2024
Salary / Pay Rate: $32.00 - $48.82 / hour
Application Deadline: Open Until Filled
Job Description
Join the forefront of groundbreaking research at the Beckman Research Institute of City of Hope, where we're changing lives and making a real difference in the fight against cancer, diabetes, and other life-threatening illnesses. Our dedicated and compassionate faculty and staff are driven by a common mission: Contribute to innovative approaches in predicting, preventing, and curing diseases, shaping the future of medicine through cutting-edge research.
Come join us as a Quality Assurance Associate II where you will be responsible for assisting the QA Manager and Senior QA Associate in achieving compliance with all Federal and State laws and regulations and other accrediting agency requirements in the collection, processing, preparation, and distribution of biopharmaceutical products manufactured in the Good Manufacturing Practice (GMP) facilities at City of Hope (COH).
As a successful candidate, you will:
- Perform quality assurance for equipment, building, processes, and products to ensure GMP compliance.
- Review batch records, ensuring proper procedures are used before QA Manager approval.
- Compile, archive master production, and control batch records.
- Assist QA Facilities Manager with continuous operation of mechanical systems, monitoring systems, and equipment.
- Coordinate preventative maintenance and maintain cGMP compliance for building systems and major process equipment.
- Conduct internal cGMP and safety training for manufacturing staff; provide training to new staff; lead OQS on manufacturing projects.
- Initiate OOS/CAPA investigations, propose resolutions, and process related forms.
- Write, review, and process approval of SOPs and quality policies. Handle clean room changeovers, including environmental monitoring, log checks, and equipment calibration. Present project updates and participate in audits. Interact with internal departments and external vendors as directed.
Your qualifications should include:
- BS or BA Degree.
- 3+ years of experience. Required experience may vary according to QA team focus (i.e. supporting biologics manufacturing, small molecule synthesis, GMP facility operations).
Preferred qualifications:
- MS degree preferred with 3+ years of experience or BS/BA degree with 5+ years of experience.
- Certification from ASQ or other professional organization /recognized institutions related to quality (i.e. quality auditor, quality manager, facility operations). Biotech sponsored seminars, workshops on regulations, policies, and procedures impacting cGMP/GLP activities related to biologics manufacturing.
City of Hope is an equal opportunity employer. To learn more about our commitment to diversity, equity and inclusion, please click here.
To learn more about our Comprehensive Benefits, pleaseCLICK HERE.
Salary / Pay Rate Information:
Pay Rate: $32.00 - $48.82 / hour
The estimated pay scale represents the typical [salary/hourly] range City of Hope reasonably expects to pay for this position, with offers determined based on several factors which may include, but not be limited to, the candidate’s experience, expertise, skills, education, job scope, training, internal equity, geography/market, etc. This pay scale is subject to change from time to time.
City of Hope is a community of people characterized by our diversity of thought, background and approach, but tied together by our commitment to care for and cure those with cancer and other life-threatening diseases. The innovation that our diversity produces in the areas of research, treatment, philanthropy and education has made us national leaders in this fight. Our unique and diverse workforce provides us the ability to understand our patients' needs, deliver compassionate care and continue the quest for a cure for life-threatening diseases. At City of Hope, diversity and inclusion is a core value at the heart of our mission. We strive to create an inclusive workplace environment that engages all of our employees and provides them with opportunities to develop and grow, both personally and professionally. Each day brings an opportunity to strengthen our work, leverage our different perspectives and improve our patients’ experiences by learning from others. Diversity and inclusion is about much more than policies and campaigns. It is an integral part of who we are as an institution, how we operate and how we see our future.