JT944 - QUALITY APPLICATIONS SPECIALIST

QUALITY CONSULTING GROUP, a leader in the pharmaceutical, biotech, medical devices, and manufacturing industry, is looking for a talented, highly motivated and enthusiastic to join our team. In this role, you’ll work with a highly enthusiastic team, contributing in a world-class manufacturing industry in Puerto Rico & USA

Responsibilities:

• Develops, modifies, applies and maintains quality standards and protocol for processing materials into partially finished or finished materials product.
• Collaborates with engineering and manufacturing functions to ensure quality standards are in place.
• Devises and implements methods and procedures for inspecting, testing and evaluating the precision and accuracy of products and production equipment.
• Designs or specifies inspection and testing mechanisms and equipment; conducts quality assurance tests; and performs statistical analysis to assess the cost of and determine the responsibility for products or materials that do not meet required standards and specifications.
• Ensures that corrective measures meet acceptable reliability standards and that documentation is compliant with requirements.
• May specialize in the areas of design, incoming material, production control, product evaluation and reliability, inventory control and/or research and development as they apply to product or process quality.
• Performs investigation non-conformance events, CAPA (corrective and preventive actions) and cost down activities.

Qualifications:

• Requires a Bachelor degree in Science or Engineer
• And minimum of 2 years of relevant experience, or advanced degree with 0 years of experience.
• Lean Six Sigma Green Belt Certification
• Microsoft Office (Excel, Word, Outlook, Power Point, Project), Agile, HR - ABRA Suite, Maximo, MRO Program, SAP, TEDS, Agile, Compliance Wire, Gallup On-line Tool, Factory Works
• Validation experience (IQ, OQ, PQ’s Computer System Validation development and execution)
• Investigation skills experience (NCR’s, CAPA’s)
• Identify Corrective/Preventive Actions
• Implementing Corrective/Preventive Actions
• GMP
• Good problem-solving skills
• Fully Bilingual
• Availability for 1rst shift