QA Associate II

3 weeks ago

Duarte, California, United States City of Hope Full time

Join the forefront of groundbreaking research at theBeckman Research Institute of City of Hope, where we're changing lives and making a real difference in the fight against cancer, diabetes, and other life-threatening illnesses. Our dedicated and compassionate faculty and staff are driven by a common mission: Contribute to innovative approaches in predicting, preventing, and curing diseases, shaping the future of medicine through cutting-edge research.

We are looking for a Quality Assurance Associate II to support biological manufacturing. You will be 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.

As a successful candidate, you will:

* Conduct quality assurance activities, to ensure compliance with Good Manufacturing Practices (GMP), including initiating Change Controls, investigating QMRs and CAPAs, and overseeing documentation and completion process.

* Review production output batch records and assure that the proper procedures and processes have been used in the production, prior to approval by QA Manager. You will also compile master production and control batch records and archive documents.

* Conduct external vendor audits and interact with internal COH departments as directed.

* Participate in internal audits of QA, Manufacturing, or QC processes and assist with writing audit reports.

* Train new associates on GMP, including Good Documentation Practices, Aseptic Techniques, Gowning and Safety. Additionally, you will update training records and ensure adherence to the training program.

* Conduct inventories of cold storage units when necessary and maintain inventory database.

* Be on the call list for critical equipment monitoring and respond to emergency calls as needed.

Qualifications

Your qualifications should include:

* Bachelors degree with 3+ years of experience supporting biologics manufacturing, small molecule synthesis and/or GMP facility operations. Masters degree with 3+ years of experience or Bachelors with 5+ years of experience is preferred.

* Basic background within biology, chemistry, virology or engineering

* Background within biosafety, chemical safety, cGMP principles and practices and/or equipment maintenance is preferred

* Certification from ASQ or other professional organizations/recognized institutions related to quality is not required but highly preferred

City of Hope employees pay is based on the following criteria: work experience, qualifications, and work location.

City of Hope is an equal opportunity employer. To learn more about our commitment to diversity, equity and inclusion, please click here

To learn more about our Comprehensive Benefits, pleaseCLICK HERE.

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