QA Associate - I in El Segundo, CA at Integrated Resources, Inc

Date Posted: 1/4/2020

Job Snapshot

Job Description

Specialist I, Quality Assurance

We are seeking a highly motivated individual to join us as a Specialist I, QA Operations at the commercial manufacturing site in El Segundo. In this role, you will ensure quality product and timely delivery every patient every time.

Responsibilities (included but not limited to):
Perform receipt and disposition of incoming apheresis material.
Perform verification/inspection and ensure timely issuance of production documents and labels
Review batch-related documentation, and ensure resolution of issues to release and ship product.
Ensure timely resolution and escalation of issues in operations
Ensure all product-related Deviations are initiated, investigated and resolved.
Ensure that associated CAPAs are initiated and resolved, as needed.
Ensure approval and timely delivery of final product.
Ensure products are manufactured in compliance with regulatory and GMP guidelines.
Provide Quality Assurance support resolving material, in-process product, final product, environmental, facility and equipment manufacturing issues.
Gather metric information for use in continuous improvement of areas of responsibility.

Qualifications:
BS/BA + 5 yrs. experience in a GMP related field within a biotechnology, biologics, or pharmaceutical manufacturing facility.
Works on multiple assignments in collaborative and dynamic environment.
Working knowledge and ability to apply GMPs in conformance to U.S., EU, and ROW standards
Ability to effectively negotiate and build collaboration amongst individuals
Strong teamwork and collaborative skills
Experience with manufacturing investigations, deviations, and CAPA.
Experience with change control practices and strategies.
General knowledge of aseptic manufacturing processes.
Proficient in MS Word, Excel, Power Point and other applications.
Strong interpersonal, verbal and written communication skills
Comfortable in a fast-paced environment and able to adjust workload based upon changing priorities