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UPS · 15 hours ago

QA Associate I - Life Sciences / Pharmaceuticals

Inglewood, CA

Full-time

Onsite

New Grad, Entry Level

$44/hr - $44/hr

UPS is a Fortune Global 500 organization that specializes in healthcare precision logistics. The CGT Quality Assurance Associate is responsible for overseeing the implementation of the Quality Management System and ensuring compliance with regulations and client requirements in the Cell & Gene Therapy Network.

LogisticsMessagingTransportation

No H1B

U.S. Citizen Only

Responsibilities

Implement, promote and maintain Marken’s Global Quality Management System (QMS) requirements

Assist in the Management of deviations, complaints, audit records, CAPA plans, change controls, collation of quality metrics and trending, and identification and implementation of quality improvement initiatives

Evaluate the risk and impact of changes within scope of the CGT/QA team and advise on necessary actions, as applicable

Interact with clients on Quality Assurance (QA)/ GxP related matters under management supervision

Assist in internal audits including tracking of associated corrective and preventative actions (CAPA)

Support Client audits and Regulatory Inspections- participate as a QA SME, prepare requested materials, review/approve Marken audit responses, follow up on CAPA identified

Effectively interact with Marken operational departments and stakeholders to provide guidance and quality oversight of all CGT activities ensuring alignment to Marken’s QMS

Identify relevant GxP/Quality related training needs and deliver or make they are deliver where required

Write the quality processes and procedures associated with job role with management guidance and effective controlled document approval

Keep informed of regulatory changes within assigned Country/Region and promptly escalate changes to management

Assisting in the evaluation of Marken-designated vendors and/or out-sourced activities

Ensuring the accuracy and quality of records and documents

Participate actively in all the internal Quality, CGT and/or other pertinent meetings

Travel may be required for the performance of duties

Qualification

Manufacturing PracticesDistribution PracticesDocumentation PracticesBachelor’s degree in Life SciencesSix Sigma green beltMicrosoft OfficeCollaboration with stakeholdersCommunication skills

Required

Bachelor's degree in a Life Sciences field required

Demonstrated knowledge of Good Manufacturing Practices, Good Distribution Practices, Good Documentation Practice guidelines

Related knowledge of local regulations

Relevant technical experience and/or quality experience in a GxP industry or the equivalent combination of relevant education and professional experience

Demonstrated ability to effectively communicate and collaborate with direct stakeholders including with customers, vendors, equipment suppliers, and operations staff

Excellent verbal, written, and interpersonal communication skills

Intermediate experience with Microsoft Office Suite

Must be a U.S. Citizen or National of the U.S., an alien lawfully admitted for permanent residence, or an alien authorized to work in the U.S. for this employer