QA Associate - I

Proclinical is currently recruiting for a Quality Assurance Associate - I (QA Operations Specialist) with an international biopharmaceutical company located in El Segundo, CA. Successful candidate will ensure quality product and timely delivery to every patient every time.

Job Responsibilities:

• 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.
• Guarantee timely resolution and escalation of issues in operations
• Ensure all product-related Deviations are initiated, investigated and resolved.
• Works on multiple assignments in collaborative and dynamic environment.
• Ensure that associated CAPAs are initiated and resolved, as needed.
• Certify 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.

Skills and Requirements:

• BS/BA + 5 yrs. experience in a GMP related field within a biotechnology, biologics, or pharmaceutical manufacturing facility.
• 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.

To Apply:

Please click on the Apply button. Please include a short note outlining why you are interested in the role and why you think you are suitable.

In case you have difficulty in applying or if you have any questions, please call Brendan Thalheimer at (+1) 215-531-5299 or upload your resume on our website - www.proclinical.com.

A full job description is available on request.

Proclinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.

Proclinical Staffing is an equal opportunity employer.

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