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QA Auditor - Gurabo, PR

Kelly Services


Location:
Gurabo, PR
Date:
06/06/2018
2018-06-062018-07-05
Job Code:
US653NLA_BH1443515
Kelly Services
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Job Details

Job Title QA Auditor - Gurabo, PR

Jobid US653NLA_BH1443515

Location: Gurabo, PR, 00778, USA

Description 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 a Parenteral 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 Forms 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 all 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 Sr. 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 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 ect.)
+ 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
**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!** at http://www.kellycareernetwork.com/

_*_ _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 relevantprojects. Our connections can lead you to innovative scientific pursuits you’ll be proud to helpadvance. We work with 95 of the Fortune 100™ companies, and found opportunities for more than 9,000scientific professionals last year.

You pursued a career in science to fuel your quest for knowledge and your desire to make the worlda better place. Let Kelly fuel your career—connect with us today.

**AboutKelly 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 connectwith 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 iscommitted to employing a diverse workforce. Equal Employment Opportunityis The Law.



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