QA Associate I-CATD
City of Hope, an innovative biomedical research, treatment and educational institution with over 5,000 employees, is dedicated to the prevention and cure of cancer and other life-threatening diseases and guided by a compassionate, patient-centered philosophy.
Founded in 1913 and headquartered in Duarte, California, City of Hope is a remarkable non-profit institution, where compassion and advanced care go hand-in-hand with excellence in clinical and scientific research. City of Hope is a National Cancer Institute designated Comprehensive Cancer Center and a founding member of the National Comprehensive Cancer Network, an alliance of the nationâ€™s 20 leading cancer centers that develops and institutes standards of care for cancer treatment.
Requisition ID: 13425
Job Title: Quality Assurance Associate I - CATD
Position Summary and Key Responsibilities:
Responsible for assisting the Quality Assurance Manager (QAM) and the 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 biological products manufactured in the GMP facilities at City of Hope (COH). Responsibilities include materials management, environmental monitoring, raw materials testing, equipment management, document preparation & control and other Quality Assurance support activities as assigned. Required to wear pager, or other communication devices, and respond to emergency calls.
- Performs quality assurance activities for equipment, building, processes and products to ensure compliance with Good Manufacturing Practices (GMP).
- Conduct routine facility monitoring tasks.
- Review and process controlled documents.
- Provide validation/preventative maintenance support for critical equipment.
- Assist with distribution, tracking and archiving of biologics.
- Participate in all QS team meetings and attend relevant training as approved by Director.
- Participate in the efforts in achieving compliance with all Federal and State accrediting agency requirements.
- No supervisory responsibilities, but may coordinate activities of lab aide/assistant staff as directed.
- Wear pager, or other communication devices, and respond to emergency calls.
Minimum Education and Skills Required for Consideration:
- Technical Certification with 0-2 years of related experience
- Experience may substitute for minimum education requirements.
- Basic biology, chemistry or engineering required
- Foster and promote a positive image and professional appearance
- Autonomous and self-directed
- Demonstrated laboratory skills
- Knowledgeable about State and Federal regulatory requirements
- Excellent writing skills required, including grammar and spelling. Able to correctly use technical terms and abbreviations
- Excellent organizational skills
- Bachelor of Science or Associate degree in biology, chemistry, Engineering or related field with 0 â€ 2 years of experience preferred
- Basic Biology (Molecular and Cellular) Chemistry (Inorganic, Organic and Biochemistry). Biosafety courses, chemical safety, cGMP principles and practice, equipment maintenance.
- Certification from ASQ or other professional organization /recognized institutions related to quality (i.e. facility operations).Biotech sponsored seminars, workshops on regulations, policies, and procedures impacting cGMP/GLP activities related to biologics manufacturing.
- Biotechnology, Pharmaceutical industry experience
City of Hope is committed to creating a diverse environment and is proud to be an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, religion, color, national origin, sex, sexual orientation, gender identity, age, status as a protected veteran, or status as a qualified individual with disability.