QA Associate I - Life Sciences / Pharmaceuticals

UPS•Inglewood, CA

About The Position

Marken, UPS Healthcare Precision Logistics (formerly Marken, MNX & Polar Speed), the clinical and advanced therapy subsidiary of UPS Healthcare, unites expertise across healthcare and complex secure logistics to drive the success of our clients through innovation. Main Purpose: The CGT Quality Assurance Associate (CGT QAA) is responsible for the oversight and implementation of the Marken Quality Management System (QMS), Marken Standard Operating Procedures (SOPs), processes and policies required to manage and control Marken’s Cell & Gene Therapy Network. The CGT QAA also needs to ensure compliance with applicable regional and local regulations and requirements, and client requirements as appropriate, but not limited to: current Good Manufacturing Practice (GMP), Good Distribution Practices (GDP), Good Documentation Practices (GDocP), 21 CFR Part 210 and 211.

Requirements

BA in Life Sciences area or QA experience within the Pharmaceuticals Industry.
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.

Nice To Haves

Knowledge of cold chain supplies preferred.
Knowledge of drug product logistics, storage and distribution preferred.
Six Sigma green belt or equivalent experience is desired.

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.