QA Specialist - II

Proclinical is currently recruiting for a Quality Assurance Specialist - II position with an international biopharmaceutical company located in El Segundo, CA. Successful candidate will be responsible for working in partnership with Manufacturing operations, Quality control and Quality Assurance, Engineering, Maintenance and support areas to provide expertise on compliance issues relating to implementation of Electronic Batch Record (EBR) and maintain workflows consistent with corporate initiatives.

Job Responsibilities:

• Serve as the primary lead and expert for Electronic Batch Record (EBR) project implementation and changes to the systems or applications.
• Contribute to the design and development of EBR, including the design of workflow, validation, and participation in UAT, deployment.
• Analyze business issues and discern their implications for system support.
• Provide Quality guidance on EBR project development.
• Proficient in cGMP regulations, quality systems, and regulatory requirements.
• Develop and/or review GMP documents and ensure compliance with company procedure and applicable regulatory requirement.
• Support Maintenance of EBR system and processes to ensure compliance with the regulations such as GMPs, and 21 CFR Part 11.
• Work closely with and provide Quality oversight across the Manufacturing and IT departments within Kite and externally to assure compliance.

Skills and Requirements:

• Minimum of 7 years progressive experience in pharmaceutical or biologics quality systems roles; cell therapy experience preferred.
• Experience in Computerized System Validation.
• Software support experience with large scale applications (e.g., MES).
• Hands on experience on computerized systems such as EBR, and LIMS including knowledge of regulatory requirement (FDA 21 CFR Part 11, EU Annex 11) for validated systems.
• BS in Engineering or Computer Science degree with over 5 years of relevant experience in a regulated industry or Bachelor's degree in biological sciences or related field.
• Ability to work independently, with minimal supervision.
• Experience in PAS-X software preferred.
• Experience in validating or implementing Electronics Batch Record, MES.

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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