QA Associate II-CATD
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. Provides validation support for all equipment, processes, and approves all outcomes, which are essential to the production of biotechnical products. This includes the documentation of processes and maintenance of records. Assists with audits, inspections, and staff in-service training as necessary. Responsible for operation and maintenance of facility monitoring systems.
- Performs quality assurance activities for equipment, building, processes and products to ensure compliance with Good Manufacturing Practices (GMP).
- Reviews and compiles master production batch and control batch records
- QA project lead for manufacturing campaigns
- Conducts and reviews routine facility monitoring tasks.
- Writes, Review and process controlled documents.
- Provide validation/preventative maintenance support for critical equipment and write associated protocols.
- Maintains and creates QS tracking databases.
- Participate in the efforts in achieving compliance with all Federal and State accrediting agency requirements.
- No supervisory responsibilities, but may provide training to new staff. Will be the QS lead on manufacturing projects as assigned. Coordinate activities of lab aide/assistant staff as directed.
- 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). Assist QS in establishing and maintaining Quality Systems as they pertain to facility operation.
- Writes, reviews and processes the approval of Standard Operating Procedures.
- Assists in internal inspections and audits (manufacturing, QC, safety) to ensure compliance with Federal Drug Administration (FDA) regulations and City of Hope and QS policy requirements.
- 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. Assists QC in the review of product COA. Compile master production and control batch records.
- Initiate OOS/CAPA investigations, propose resolutions and process related forms.
- When necessary, assist with receiving, acceptance, handling, and storing of raw materials.
- Assist in QS streamlining activities.
- Responsible 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 Manager.
- Serve as department safety representative as directed by the QA Manger.
- Assist in the preparation of cGMP training program and conducts staff cGMP-training as necessary and maintains documentation.
- Cooperates with other performance improvement and compliance activities in the institution.
- Represents Quality Assurance function through interaction with Principal Investigators as directed by QA Manager.
- Maintains knowledge of current regulatory/accreditation requirements, changes and issues, inspection citations, quality assurance training, management, and organizational development activities.
- Maintains and creates databases to track and trend monitoring data including environmental monitoring, equipment maintenance, excursions in facility operations. Analyze trends and generate reports/updates from these databases.
- Wear a QS issued pager, or other communication devices, and promptly respond to all emergency calls for critical equipment failure at all times.
- Internal Contacts: Communicate with all manufacturing, QC and QS staff as it relates to document review & approval, master production and control batch record compilation, release test coordination, materials release/storage and facility/equipment maintenance issues. Conduct internal audits, follow-ups and write report for QAM or Senior QA Associate. Conduct internal cGMP and safety training. Train new QS personnel. Communicate with limited COH departments for project related issues. Present project updates at project meetings and to management as requested. Present routine updates at QS team meetings.
- External Contacts: Interact with external collaborators at project meetings and present project updates. Interact with other COH departments as directed. Communicate with external vendors as directed, to coordinate release tests activities and materials processing.
- Budget/Financial Administration: Track facility and project related costs (i.e. gowning supplies, process gases) for QA Manager or Senior QA Associate.
- May be required to conduct external vendor audits
- May be required to attend off-campus training or COH training seminars.
- May be required to archive documents.
Follows established City of Hope and department policies, procedures, objectives, performance improvement, attendance, safety, environmental, and infection control guidelines, including adherence to the workplace Code 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 Education and Skills Required for Consideration:
- Bachelor of Science or Associate Degree with 3 – 5 years of experience. Masters of Science with 0 – 4 years of experience.
- Required Courses/Training: Basic biology, chemistry, virology or engineeringPrefer training in basic Biology (Molecular and Cellular), Chemistry (Inorganic, Organic and Biochemistry), and GMP facility operations. Also, biosafety courses, chemical safety, cGMP principles and practice, equipment maintenance.
- Prefer 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.
- Ability to 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.
About City of Hope
City of Hope, an innovative biomedical research, treatment and educational institution with over 4000 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.
City of Hope is 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.
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