Sr. Quality Systems Analyst

Proclinical, in support of a growing pharma company, is seeking an individual to fill the role of Quality Systems Analyst-PLM, based in Irwindale, CA. The successful candidate will analyze and support the business within the realm of quality systems software.

Responsibilities

• Manage, analyze, and update, quality systems software. Perform basic configuration and administrative changes for same.
• Collaborate with IT support team to address any software issues/project discussions.
• Collaborate with IT, CSV, and the business owner in evaluating and reviewing system-related enhancements and fixes to the Quality Systems software.
• Make recommendations to supervisor to improve department's operating efficiency.
• Author and support validation documentation deliverables.
• Train testers in performing validation tests.
• Ensure software systems' inspection readiness.
• Support the business in audits, review audit non-conformity action plans and closure of internal audit findings related to the Quality Systems software.
• Recommend issue resolution to impacted functions for significant capability and compliance issue.
• Ensure personal and company compliance with all relevant policies and procedures.

Skills And Qualifications

• BA in related field (business, science or engineering preferred) and 2-4 years of relevant experience.
• Knowledge of GDP, and FDA and ISO standards.
• Experience in authoring procedures and work instructions.
• Experience in and knowledge of software development life cycle methodology.
• Able to lead and/or attend meetings, whether in person or teleconference.
• Experience in Quality Systems processes and ERP software.
• Experience with system/software development methodology.
• Experience with computer system validation support.
• Experience with supporting internal audits and inspections by regulatory authorities
• Proficiency in Microsoft Office suite and Adobe Acrobat.
• Excellent written, verbal, and interpersonal communication skills.

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 Samantha Reader at (+1) 3368428680 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.

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