QA Associate II-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 nation's 20 leading cancer centers that develops and institutes standards of care for cancer treatment.
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.
- 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.
Follows established City of Hope and department policies, procedures, objectives, performance improvement, attendance, safety, environmental, and infection control guidelines, includingadherence to theworkplaceCode of Conduct and Compliance Plan. Practices a high level of integrity and honesty in maintaining confidentiality.
Performs other related duties as assigned or requested.
- Minimum BS or BA Required
- 3 5 years of experience
- Basic biology, chemistry, virology or engineering
- MS degree preferred w/0 3 years of experience.
- Basic Biology (Molecular and Cellular) Chemistry (Inorganic, Organic and Biochemistry)
- GMP facility operations
- Biosafety courses, chemical safety, cGMP principles and practice, 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.
- Required: Excellent written and oral communication skills, team player, self-motivated, excellent personal hygiene, practice good judgment in all professional activities. Ability to analyze data and compose reports. Ability to set and model professional work standards.
- Foster and promote a positive image and professional appearance
- Autonomous and self-directed
- Demonstrated laboratory skills
- Knowledgeable about State and Federal regulatory requirements
- Able to correctly use technical terms and abbreviations
- Excellent organizational skills
- Microsoft Access Database: Required
- Microsoft Excel: Required
- Microsoft Windows NT: Required
- Microsoft Word: Required
- Microsoft Project / PowerPoint: Preferred
- Labware / LIMS: Preferred
- Personal computer: Required
- Photocopier: Required
- Audiovisual equipment: Required
- Environmental monitoring equipment: Preferred
- Autoclave, Glassware washer, Depyrogenation oven, RODI system, and Pure Steam Generator: Preferred
Working / Environmental Conditions:
- State of the art GMP drug manufacturing facility.
- Exposed to materials of confidential nature on a regular basis.
- Atmosphere and environment associated with an office setting
- Atmosphere and environment associated with a laboratory
- Tobacco-free campus
- Subject to many interruptions
- Subject to long irregular hours
- Occasional pressure related to timeframes
- May require a flexible work schedule
- Subject to regularly changing priorities and work assignments
- Gowning according to facility requirements. This includes hair covers, shoe covers, gloves, facemasks, eye protection; occasionally full one piece suits with hoods. Other safety precautions and practices as specified by the City of Hope safety regulations
- Light physical effort (lift/carry up to 20 lbs.)
- Frequest Walking
- Some reaching, stooping, bending, kneeling, crouching
- Tasks require focused concentration
- Comfortable on high exposed work places (roof).
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.