QA Associate II

About City of Hope

City of Hope, an innovative biomedical research, treatment and educational institution with over 6000 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 nation's leading cancer centers that develops and institutes standards of care for cancer treatment.

Position Summary:

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 GMP facilities at City of Hope (COH). Assists with distribution, tracking and archiving of clinical materials. Assists with audits, inspections, and staff in-service training as necessary.

Key Responsibilities include:

• Performs quality assurance activities for equipment, building, processes and products to ensure compliance with Good Manufacturing Practices (GMP).
• Reviews production output batch records and assures that the proper procedures and processes have been used in the production of the products prior to approval by QA Manager. Compile master production and control batch records and archive documents.
• Assists QA Facilities manager for the continuous operation of the facility's mechanical systems, monitoring systems and equipment. Responsible for co-coordinating preventative maintenance and maintaining cGMP compliance of all building systems and major process equipment (e.g. autoclaves, dishwashers, depyrogenation oven), as directed by QA Facilities Manager.
• Conduct internal cGMP and safety training to manufacturing staff, may provide training to new staff and will be OQS lead on manufacturing projects.
• Initiate OOS/CAPA investigations, propose resolutions and process related forms.
• Writes reviews and processes the approval of Standard Operating Procedures and quality policies.
• Responsible for clean room changeover activities such as performing Environmental monitoring, checking room logs, equipment calibration and trash.
• Present project updates at project meetings and to management as requested. Participate in audits and interact with COH collaborators. May be required to attend off-campus training or COH training seminars.
• May be required to conduct external vendor audits. Interact with internal COH departments (purchasing, safety etc) as directed. Communicate with external vendors as directed, to co-ordinate release test activities, and materials processing.
• Wear pager, or other communication devices, and respond to emergency calls as needed.

Basic education, experience and skills required for consideration:

• Bachelors degree within life sciences or related field with a background in basic biology, chemistry, virology or engineering
• 3+ years of experience supporting biologics manufacturing, small molecule synthesis, and/or GMP facility operations

Preferred education, experience, and skills:

• Masters degree preferred with 3+ years of experience or BS/BA degree with 5+ years of experience.
• Basic Biology (Molecular and Cellular) Chemistry (Inorganic, Organic and Biochemistry)
• Background within GMP facility operations, biosafety, chemical safety, cGMP principles and practice, and/or equipment maintenance.
• 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.

Additional Information:

• To protect the health of patients and staff and to comply with new State of California mandates, City of Hope staff are required to show proof of full vaccination by September 30, 2021. Compliance is a condition of employment.

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.

• Posting Date: Sep 20, 2021
• Job Field: Research
• Employee Status: Regular
• Shift: Day Job