Overview
QA Associate III Jobs in San Diego, California, USA at The University of Texas MD Anderson Cancer Center
Job **QA Associate III
Job * 35876
* San Diego,CA
Job Description
Responsibilities include batch record review, deviation investigation, label issuance, and tracking, issuing, distributing, and archiving documentation.
Responsibilities
Assist in the production of clinical products by reviewing and disposing of batch records, printing labels, packaging products, and managing shipments.
A solid understanding of 21 CFR 210 and 211, ICH, ISO
9001, EU Guidelines, and other applicable FDA regulations is essential.
Conduct or oversee investigations into deviations, implement corrective and preventive actions (CAPA), manage change controls, lead company-wide training sessions, and perform internal audits. Prepare related reports.
Process controlled documents within the GxP (GLP/GCP/GMP) system, including tasks like word processing, tracking, issuing, distributing, and archiving, using either manual or electronic document management systems.
Collaborate in developing, refining, and implementing training programs and other quality management systems as needed.
Coordinate, track, and maintain controlled records (e.g., batch/test records, logbooks, validation documents, labels, reports, and forms) for change controls, deviations, CAPAs, audits, training, equipment calibration, and preventative maintenance.
Write and/or review policies, standards, procedures, and work instructions to document quality management practices.
Assist with supplier management activities.
Manage inventory databases, ensuring accurate and timely updates of lot numbers and quantities.
Review and release incoming materials.
Support regulatory and submission processes.
Prepare materials for Management Review and Material Review Board meetings.
Carry out other duties as assigned.
Required Skills
A Bachelors Degree and 3-5 years of experience in a cGMP setting.
Experience with a commercial cell therapy company is highly preferred.
Knowledge of Aseptic Processing is an advantage.
Strong attention to detail and excellent record-keeping abilities.
Proficient in MS Word, Excel, Visio, Access, Adobe Suite, and database systems.
Effective verbal and strong written communication skills.
Familiar with Quality Systems and record management in a cGMP environment.
Excellent problem-solving abilities and the capability to manage multiple tasks simultaneously.
Results-driven with a commitment to compliance and customer service.
Proactive, independent, and able to follow through on tasks.
Able to thrive in a fast-paced, cross-functional team environment with changing priorities.
Willingness to gown and work in a classified area when necessary.
Perks and *
Comprehensive medical, dental, and vision coverage
Salary ****$80,000 – $95,000 per year
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Title: QA Associate III
Company: The University of Texas MD Anderson Cancer Center
Location: San Diego, California, USA
Category: Quality Assurance – QA/QC, Healthcare
