Kelly Services is currently seeking a QA AUDITOR for one of our top clients in Gurabo, PR
Responsible for ensuring a product or service meets the established standards of quality including reliability, usability and performance
- 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.
- 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
- 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*
* Must comply with minimum established requirements to qualify.
Apply on company website