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1+ months

Senior Cell Therapy QA Specialist

Kelly Services
Los Angeles, CA 90006
**Kelly Science and Clinical** is the worlds most recognized brand in science and clinical staffing with more than 100 locations in North America, Europe, and the Pacific Rim. Our scientists contribute to the research and development of the next generation of small molecule drugs, biologics and cellular therapies.


**Overview**


We are seeking a Quality Assurance Specialist for one of our clients, leading academic institution in the Los Angeles area. cGMP Quality Assurance Specialist. The incumbent will manage the Quality Assurance system for manufacturing cell and gene therapies and other biological products for internal/external users in the Good Manufacturing Practices cGMP facility. The Quality Assurance Specialist is responsible for ensuring operations quality and compliance with current Good Manufacturing Practice cGMP regulations. Establishes, controls, monitors and records all activities, which directly/indirectly impact aspects of cell therapy product quality. Establishes a Corrective and Preventative Actions CAPA system that manages the response to errors, accidents, complaints and clinical trial-related adverse events. Ensures that cell therapy products have been produced within established process and release requirements.


**Responsibilities**


+ Supports cGMP manufacturing operations, with responsibility for quality assurance QA. Manages internal quality improvement initiatives, evaluates internal processes, and suggests, designs, and implements improvements.

+ Provides QA support for validations e.g., reviewing facility operations plans, training programs, standard operating procedures as required.

+ Provides support with batch record documentation, all appropriate equipment log entries, and cGMP documentation.

+ Manages the supplier/vendor qualification process in support of cGMP activities.

+ Reviews and approves raw material specifications.

+ Supervises and directs junior staff to achieve project goals.

+ Serves as a resource to cGMP facility management in identifying and assessing the appropriate complement of resources and support needed to successfully implement and execute projects.

+ Establishes and oversees self-auditing program to ensure facilities continual compliance with relevant regulatory requirements, working with external inspectors as needed.

+ Manages the CAPA process, ensuring remedial actions are taken and documented when test systems deviate from established performance specifications.

+ Works with senior staff to ensure facilities compliance with all applicable regulations. Assists with validation, routine performance, and process and analytical method development to support cell therapy products.

+ Attends routine meetings with management team for progress reports on projects, facility needs, and discussion of any other required items.

+ Promotes an environment that fosters inclusive relationships and creates unbiased opportunities for contributions through ideas, words, and actions that uphold their code of ethics

+ Performs other related duties as assigned or requested.


**Qualifications**


+ Demonstrated knowledge of all aspects of biotechnology and cell therapy. Demonstrated passion for solving complex scientific issues.

+ Experience with Food and Drug Administration regulations and clinical trials.

+ Strong communication and writing skills with demonstrated ability to work as an individual contributor and in a dynamic team environment.

+ Bachelors degree in a scientific discipline e.g., pharmaceutical, biologics.

+ Three years of experience in cellular or biological manufacturing with quality assurance responsibilities.

+ Demonstrated knowledge base with Good Manufacturing Practices e.g., cGMPs, GLPs, GDPs.

+ Experience with and knowledge of standard operating procedures in a cGMP laboratory setting. Demonstrated ability to work as an individual contributor


\#P1


**You should know:** Your safety matters! Vaccination against COVID-19 may be a requirement for this job in compliance with current client and governmental policies. A Kelly recruiter will confirm and share more details with you during the interview process.


**Why Kelly** **** **?**


Kelly Science & Clinical is your connection to premier scientific and clinical companies looking to hire talented people just like you. Every day, we match science professionals with dream jobs that fit their skills and interestsits the way we think job searching should be. Nearly 100 percent of our science recruiters have a professional background/education in science, so we know a thing or two about the science market and how to get you noticed.


**About Kelly** ****


At Kelly, were always thinking about whats next and advising job seekers on new ways of working to reach their full potential. In fact, were a leading advocate for temporary/nontraditional workstyles, because we believe they allow flexibility and tremendous growth opportunities that enable a better way to work and live (plus, did we mention we provide a ton of benefits ?). Connecting great people with great companies is what we do best, and our employment opportunities span a wide variety of workstyles, skill levels, and industries around the world.


Kelly is an equal opportunity employer committed to employing a diverse workforce, including, but not limited to, minorities, females, individuals with disabilities, protected veterans, sexual orientation, gender identity. Equal Employment Opportunity is The Law. (https://www.dol.gov/ofccp/regs/compliance/posters/ofccpost.htm)
Posted: 2022-05-02 Expires: 2022-08-22

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Senior Cell Therapy QA Specialist

Kelly Services
Los Angeles, CA 90006

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