QA Associate II
Responsible for assisting the T Cell Therapeutics Research laboratory (TCTRL) in achieving compliance with all COH institutional and Quality Systems (QS) rules and regulations in the collection, processing, preparation, and distribution of TCTRL cellular products manufactured in the GMP facilities at City of Hope (COH). Assists with distribution, tracking and archiving of clinical materials. Provides support for all equipment and processes which are essential to the quality control (QC) release of TCTRL cellular products. This includes the documentation of processes and maintenance of records. Assists with audits, inspections, and staff in-service training as necessary.
- Performs quality assurance (QA) activities for TCTRL cellular product QC-related equipment and processes to ensure compliance with Good Manufacturing Practices (GMP).
- Reviews and compiles master production batch and control batch records.
- Conducts and reviews routine TCTRL monitoring tasks.
- Writes, reviews, processes and issues controlled documents.
- Provides validation/preventative maintenance support for critical equipment and writes associated protocols.
- Maintains and creates TCTRL tracking databases (i.e., Filemaker).
- No supervisory responsibilities, but may provide training to new staff. Will be the QA lead on QC and correlative study projects as assigned. Coordinates activities of lab aide/assistant staff as directed.
- Acts as a contact for quality issues that need resolution, following up on plans to address those issues.
- Assists COH QS in establishing and maintaining QA as it pertains to TCTRL operation.
- Writes, reviews and processes the approval of TCTRL Standard Operating Procedures.
- Assists in internal inspections and audits (manufacturing, QC, safety) to ensure compliance with COH and QS policy requirements.
- Reviews QC assay records and assures that the proper procedures and processes have been used in the release of cellular products prior to approval by QC Supervisor. Assists QC in the review of product COA.
- Initiate OOS/CAPA investigations, propose resolutions and process related forms.
- When necessary, assist with receiving, acceptance, handling, and storing of raw materials.
- Assist in streamlining QC activities or communications.
- Serve as TCTRL safety representative as directed by the laboratory manager.
- Assists in the preparation of GLP training program and conducts staff GLP-training as necessary and maintains documentation.
- Cooperates with other performance improvement and compliance activities in the institution.
- Maintains and creates databases to track and trend monitoring data including assay deviations and corrective action/preventative action plans (CAPAs). Analyze trends and generate reports/updates from these databases.
- Communicates with all manufacturing, QC and QS staff as it relates to document review and approval, master production and control batch record compilation, release test coordination, materials release/storage and equipment maintenance issues. Conducts internal audits, follow-ups and assists with internal GLP and safety training. Communicate with limited COH departments for project related issues. Presents project updates at project meetings and to management as requested. Presents routine updates at TCTRL team meetings.
- Interacts with external collaborators and contractors, as well as with other COH departments as directed. Communicates with external vendors as directed, to coordinate release tests activities and materials processing.
- Budget/Financial Administration: Draft TCTRL QC and correlative assay expenses.
- 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 required. Masters of Science with 2 – 4 years of experience preferred.
- Basic biology, chemistry, and immunology courses or training.
- Biosafety courses, chemical safety, GLP principles and practice courses or training is preferred.
- Quality control and quality assurance experience is preferred.
- Ability to work under tight deadlines and prioritize tasks.
- Excellent oral and written communication skills, including grammar and spelling; able to correctly use technical terms and abbreviations.
- Excellent organizational skills. Attend to details and be methodical.
- Ability to effectively use discretionary initiative and judgment when handling confidential information.
- Superior interpersonal relationship and/or collaborative skills.
- Knowledge of Excel and Word required, knowledge of MS Project and PowerPoint is preferred.
See the Stephen Forman, M.D. web page for an overview of TCTRL research interests at: http://www.cityofhope.org/people/forman-stephen&view=research
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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