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QA AUDITOR-DISPOSITION, Gurabo PR

Kelly Services


Location:
Gurabo, PR
Date:
04/23/2018
2018-04-232018-05-22
Job Code:
US653NLA_BH1424942
Categories:
  • Healthcare
  • Monitoring
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Job Details

Job Title QA AUDITOR-DISPOSITION, Gurabo PR

Jobid US653NLA_BH1424942

Location: Gurabo, PR, 00778, USA

Description Kelly Services is currently seeking a **QA Auditor - Disposition** for one of our top clients in **Gurabo, PR**

**QA Auditor Disposition**

**Summary:**

Responsible for monitoring and maintaining product status reports shipments, bulk availability, raw material and others. Monitoring the Open Inspection Lots and provide support to close them. Support the delivers the Batch Records to Documentation Center Area. Performs all metrics, reports and presentations related to Quality Metrics. Provides support to QA Disposition to assure the timely release of lots. Collaborate with Operations, Logistics, Warehouse and QC Laboratories to solve potential compliance issues in a proactive way to support the delivers of the product on time. Responsible to generate release documents and to support regulatory/compliance special requests.

**Responsibilities:**


+ Person will support Batch Records delivers from APQA QA Disposition Area to Documentation Center Area.
+ Person will be responsible for generating all metrics, reports and presentations related to generate Quality Metrics specifically for APQA Manufacturing IR OROS/New Product, Packaging Area and Disposition Area.
+ Reviews / evaluate the final release of the WIP s, Intermediate Stages, Finished Good and/or Raw Materials API and Excipient batches to ensure compliance with all material specifications, current Good Manufacturing Practices, approved written procedures, Company Global Standards and Quality Agreements before a batch is released, distributed, rejected.
+ Identifies and evaluates related documentation such as and not limited to Investigations Events and Deviations , Change Controls, Protocols, Reports, Validation documents and Cleaning Validation Notifications to determine materials batch final disposition for distribution or rejection
+ Generates Customer requirements CoA, CoC, CoM, CoR, etc. on a timely manner.
+ Performs other duties as required by the team to support product Order Release Disposition Group activities.
+ Complies with the principles of conduct as expressed in our company Credo during all work-related activities and/or out of plant activities.
+ Ensures a safe environment according current Safety Policies and Procedures. Informs and takes action immediately if any unsafe situation is detected.
+ Observes all company policies, procedures, programs, systems, rules, and regulations at all times of all compliance areas including but not limited to Safety, Environmental, Quality, Records Management, Human Resources, Security, and others.
+ Runs SAP Inventory System Reports to monitor materials and products cycle that may impact compliance matters at the Site.
+ Keeps current with Industry Standards and Regulations.
+ Maintains the QA Disposition SharePoint updated.
+ Maintains the Reliability board updated.
+ Prepares weekly and/or monthly reports.
+ Provide support in any QA activities.
**Requirements**


+ Bachelor Degree in Science with a major in Microbiology, Biology, Chemistry or related science
+ Minimum of three 3 years in Pharmaceuticals environment.
+ Fluent in Spanish and English and excellent ability to write in English and Spanish
+ Organizational skills, detail-oriented, multi-tasking and prioritization skills.
+ Good communication and interpersonal skills.
+ Proficient in the use of MS Office applications Word, Excel, Power Point, Outlook , eLIMS and SAP.
+ Statistical knowledge.
+ Experience on metric reports and business presentations preparation.
+ Ability to work under deadlines and fast paced work environment.
**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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