Kelly Services is currently seeking a QA AUDITOR for one of our top clients in Gurabo, PR SUMMARY Responsible for ensuring a product or service meets the established standards of quality including reliability, usability and performance RESPONSIBILITIES Perform and document Process and Facility Quality Audit in Manufacturing and Utility Areas according to established Procedures, cGMP and company Standards. Evaluate Process and Facility audit findings and ensure the implementation of appropriate corrective actions (with supervisor). Coordinate and conduct AQL Inspection to finish Parenteral Products and monitor testing and inspection of materials and products to ensure finished product quality Review of batch records, in-process documents, analytical data and other regulatory documentation to ensure compliance with corresponding Procedures, cGMP and company Standards. Ensure that batch records, in-process documents, analytical data, checklists, etc. are filed in an organized manner and easily retrievable. Collect and compile statistical quality data as requested by the QA Supervisor. Review and/or approve Quality Assurance, Manufacturing and Engineering SOP’s, WI ‘s and Form’s as required using as Docspace System. Perform SAP transactions to ensure good Inventory practices of Parenteral Manufacturing Materials according to the stablished Procedures, cGMP and company Standards. Promotes a safe environment with equipment and process designs that comply with company quality and safety procedures and national and local regulations. Assures all related product samples are collected according batch records requirements. Supports the Quality Assurance Supervisor to drive quality and personnel objectives to the established Company and QA Area/Department goals and objectives. Provides compliance support to Manufacturing and Packaging Operations to assure execution in compliance with cGMPs, company Global Standards, Company Policies, Quality Agreements, Batch Records, current specifications and current procedures. Evaluate current operating procedures and recommend changes to management to optimize quality oversight and production activities. Prepare required reports to communicate outcomes of quality activities (Shift Report, Documentation Error Trending Report etc.). Responsible for the completion of training in ComplianceWire within the due days. Perform activities related to quality indicators to improve the manufacturing batch record documentation process to assure compliance with regulations agencies and company Standards. Provide QA support for complaint investigations review and Change Control related to process. Comply with the Leadership Imperatives behavior and standards applicable for the role; Credo, Connect, Shape, Deliver and Lead. REQUIREMENTS Bachelor's Degree in Science is required. Major in Microbiology, Biology, Chemistry or related field (natural science). Minimum of 2 years in Pharmaceuticals environment Fluent in Spanish and English and excellent ability to write in English and Spanish. Good written and oral communication skills Proficient in the use of MS Office applications Word, Excel, Power Point, Outlook , eLIMS and SAP. Data entry skills into Excel spread sheets and/or Microsoft Word . Good data analysis and customer service orientation Why Kelly? Exposure to a variety of career opportunities as a result of our expansive network of client companies Career guides, information and tools to help you successfully position yourself throughout every stage of your career Access to more than 3,000 online training courses through our Kelly Learning Center Weekly pay Four holidays paid by year and Christmas bonus Apply Today Must comply with minimum established requirements to qualify. Why Kelly ® ? With Kelly, you’ll have access to some of the world’s highest-regarded scientific organizations— providing you with opportunities to work on today’s most challenging, research-intensive, and relevant projects. Our connections can lead you to innovative scientific pursuits you’ll be proud to help advance. We work with 95 of the Fortune 100™ companies, and found opportunities for more than 9,000 scientific professionals last year. You pursued a career in science to fuel your quest for knowledge and your desire to make the world a better place. Let Kelly fuel your career—connect with us today. About Kelly Services ® As a workforce advocate for over 70 years, we are proud to directly employ nearly 500,000 people around the world and have a role in connecting thousands more with work through our global network of talent suppliers and partners. Revenue in 2017 was $5.4 billion. Visit kellyservices.com and connect with us on Facebook , LinkedIn and Twitter . Kelly Services is an equal opportunity employer including, but not limited to, Minorities, Females, Individuals with Disabilities, Protected Veterans, Sexual Orientation, Gender Identity and is committed to employing a diverse workforce. Equal Employment Opportunity is The Law.
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