Kelly Services QA Specialist- Disposition- Guayama, PR in Guayama, Puerto Rico

Kelly Services is currently seeking a QA Specialist Disposition for one of our top clients in Guayama, PR

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.

  • Review production documents (Manufacturing/Packaging).

  • Complete final disposition (Release / Rejection) for product, Packaging components and raw materials.

  • Quarantine production . Perform Inspections (AQL)

Qualifications:

  • BS in Science or related field

  • Quality and Compliance oversight of production and warehouse activities.

  • Teamwork and problem solving skills to accomplish project tasks

  • Strong oral and written communication skills and the ability to work independently.

  • Ability to interpret and document information according to standard operating procedures.

  • Ability to review workload and determine the most efficient and effective workflow.

  • Analyzes and interprets results. Makes some basic decisions independently.

  • Makes decisions regarding the accuracy, completeness and compliance(with company policies and procedures) of documents.

  • Ensure compliance against the FDA regulations and other international regulations as needed.

  • Attention to detail with an ability to see the big picture.

  • Able to adapt to changes and unanticipated issues.

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 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.

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 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.