Chemistry Associate II - Quality Control
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.
Requisition ID: 12748
Job Title: Chemistry Associate II Quality Control
Position Summary and Key Responsibilities:
Responsibilities will include chromatographic and wet-chemical analysis of raw materials, intermediates and final product small molecules and biopolymers for clinical uses. Provide production with in-process controls and perform stability analyses. Supervise 0-1 direct reports within the quality control laboratory.
- Provide supervision to direct report, if any. Utilize proper managerial skills to accomplish assigned tasks.
- Performs release testing and analysis of small molecules and biopolymers according to CGSF SOPs and project requirements and specifications. Records results and provides records to the Quality Assurance Manager of the CGSF.
- Processes incoming raw materials, performs analysis and qualification of reagents and components for manufacturing.
- Review, interpret and sign off on analytical data and certificates of analysis as directed by the Quality Assurance Manager.
- Assists Quality Assurance Manager and CGSF Director in defining release testing requirements, developing and executing protocols, performing periodic updates and/or revisions to quality control protocols.
- Participates in QC development including the creation of Standard Operating Procedures (SOP's) and identifying suitable testing methods for release.
- Development/adaptation of new analytical methodology under limited supervision.
- Participate in general laboratory activities as assigned by supervisor.
- Complete and maintain all training required to perform assigned tasks.
- Assists in internal inspections and audits to ensure compliance with Federal Drug Administration (FDA) regulations and City of Hope and CGSF procedure requirements.
- Maintain current knowledge of analytical techniques and industry practices.
- May be required to monitor specialized processing equipment.
- Responsible for ensuring that the laboratory operates in a clean, uncluttered, safe, and efficient manner.
- Respond to calls/alarms off hours and weekends for facility systems and equipment failures.
- Coordinate with CGSF Quality Assurance Manager to ensure compliance with equipment maintenance and calibration.
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 by the CGSF Director or Quality Assurance Manager.
Minimum Education and Skills Required for Consideration:
- Bachelor's Degree required.
- 2-3 years post graduate chemical laboratory experience. M.S. degree may substitute for work experience.
- Required Courses/Training: Basic Chemistry (Inorganic, Organic and Biochemistry), Biology.
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.