Company:  Confidential

Job Title: QA Associate II/III

Job Number: 72591

Location: Los Angeles, US

Job Description

We are looking for an enthusiastic team member who possesses self-motivation and values working collaboratively. Attention to detail is crucial for this role, as we require someone who is meticulous and has a strong ability to notice even the smallest particulars. The ideal candidate should have a natural talent for organizing tasks, a determination to enhance processes, and a passion for making a positive impact on the lives of patients. The chosen individual will play a vital part in supporting the introduction and production of clinical products. Key responsibilities will include reviewing batch records, investigating deviations, issuing and tracking labels, as well as managing the distribution and archiving of controlled documentation, training, and support systems related to GLP/GCP/GMP across the company. A comprehensive understanding of the standard procedures involved in document control and previous experience in an FDA regulated environment are prerequisites for this position.

Responsibilities

* Contribute to the manufacturing of clinical products by carrying out tasks such as reviewing and approving batch records, printing labels, packaging products, and arranging shipments.  * Possess a thorough understanding of 21 CFR 210 and 211, ICH, ISO9001, EU Guidelines, and other relevant FDA regulations. * Conduct or coordinate investigations into deviations, implement corrective and preventive actions (CAPA), manage change controls, facilitate company-wide training, and conduct internal audits. * Prepare associated reports detailing findings and recommendations. * Manage controlled documentation through the GxP (GLP/GCP/GMP) documentation system, which includes word processing, tracking, issuing, distributing, and archiving documents, utilizing either a manual or electronic document management system. * Collaborate in the development, enhancement, and implementation of training programs and other quality management systems, as assigned. * Coordinate, track, and archive controlled records such as batch/test records, logbooks, validation documents, labels, reports, forms, etc., for change controls, deviations, CAPAs, audits, training, equipment calibration, and preventative maintenance. * Compose and/or review policies, standards, procedures, and work instructions to document the processes and practices related to Quality documentation. * Provide support for the supplier management program. * Manage the inventory database, ensuring accurate and timely updates of lot numbers and quantities. * Assist with regulatory and submission activities. * Prepare relevant materials and actively participate in Management Review and Material Review Board meetings.

Required Skills

* Bachelor’s Degree and 3-5 years of experience in a cGMP (current Good Manufacturing Practices) environment are required for this role.  * Previous experience in a commercial cell therapy company is highly preferred, and experience in Aseptic Processing is advantageous.  * Possess exceptional attention to detail and exemplary record-keeping skills.  * Proficiency in various computer applications such as MS Word, Excel, Visio, Access, Adobe suite, and database systems is essential.  * Effective oral and written communication skills are necessary. * Having familiarity with Quality Systems and records management in a cGMP environment is beneficial.  * Strong problem-solving abilities and the capacity to coordinate and execute multiple activities are important qualities.  * The candidate should be results-oriented with a commitment to compliance and customer service.  * Demonstrate initiative, independence, and follow-through in their work.  * Ability to thrive in a fast-paced, cross-functional team and adapt to dynamic environments is crucial.  * Comfortability with rapidly changing priorities is also required.Salary range: $85,000-115,000K annually Benefits: Health Insurance (medical, dental, vision) Life Insurance Short- and Long-Term Disability 401(k) Paid Time Off

Application Deadline: 2024-03-25

 

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