About City of Hope

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: 12167

Job Title: Senior Quality Assurance Associate

Position Summary and Key Responsibilities:

Manage Quality Assurance Staff to maximize the productivity of the group. Responsible for assuring compliance with all Federal and State laws and regulations and other accrediting agency requirements in the collection, processing, preparation, and distribution of pharmaceutical and genetic products manufactured in the GMP facilities at COH. Responsible for the smooth operation of the GMP facility and co-ordinates the activities of the QS team in support of manufacturing /QC activities. This includes the documentation of processes and maintenance of records. Conducts audits, inspections, and staff in-service training as necessary. Assumes full responsibility for materials release and distribution, facility maintenance and environmental and systems monitoring.

Position Accountabilities:

  • Oversees quality assurance activities for equipment, building, processes and products to ensure compliance with Good Manufacturing Practices (GMP).Assist QA in establishing and maintaining Quality Systems as they pertain to facility operation.

  • Approves master production batch and control batch records

  • In co-operation with QA Manager, establishes and implements QA policies for COH campus.

  • Oversees validation/preventative maintenance support for critical equipment and write associated protocols.

  • Supervise QS staff and assist in employee reviews.

  • Approve OOS/CAPA investigations.

  • Wear pager, or other communication devices, and respond to emergency calls.

Minimum Education and Skills Required for Consideration:

  • Bachelor of Science or Associate Degree with 9+ years of experience.

  • Masters of Science with 9+ years of experience orPhD with 0 3 years of experiencepreferred.

  • Basic biology, chemistry, virology or engineering

  • 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

  • Biotechnology, Pharmaceutical industry experience preferred

  • 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.

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    Senior Quality Assurance Associate Located At CA, Duarte - Job Post By: City Of Hope

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