Puerto Rico Government Job - 28601167 | CareerArc
  Search for More Jobs
Get alerts for jobs like this Get jobs like this tweeted to you
Company: Puerto Rico Government
Location: Gurabo, Gurabo, Puerto Rico
Career Level: Mid-Senior Level
Industries: Not specified

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 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.

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!

* Must comply with minimum established requirements to qualify.


 Apply on company website