Kelly Services is currently seeking a QA AUDITOR (3 positions) 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).
- Must have at least 2 years of experience within related field. 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
- Available 1st, 2nd and 3rd Shift, 12hrs shifts, w/e, and OT.
- 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.
Kelly® Science & Clinical is your connection to premier scientific and clinical companies looking to hire talented people just like you. Every day, we match science professionals with dream jobs that fit their skills and interests—it's the way we think job searching should be. Nearly 100 percent of our science recruiters have a professional background/education in science, so we know a thing or two about the science market and how to get you noticed.About Kelly®
At Kelly, we're always thinking about what's next and advising job seekers on new ways of working to reach their full potential. In fact, we're a leading advocate for temporary/nontraditional workstyles, because we believe they allow flexibility and tremendous growth opportunities that enable a better way to work and live (plus, did we mention we provide a ton of benefits). Connecting great people with great companies is what we do best, and our employment opportunities span a wide variety of workstyles, skill levels, and industries around the world.
Kelly is an equal opportunity employer committed to employing a diverse workforce, including, but not limited to, minorities, females, individuals with disabilities, protected veterans, sexual orientation, gender identity. Equal Employment Opportunity is The Law.]] About Kelly Services
Kelly Services, Inc. (NASDAQ: KELYA, KELYB) is a leader in providing workforce solutions.
Kelly offers a comprehensive array of outsourcing and consulting services as well as world-class staffing on a temporary, temporary-to-hire, and direct-hire basis.
Serving clients around the globe, Kelly provided employment to more than 540,000 employees in 2013. Revenue in 2013 was $5.4 billion.
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