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Batch Record Reviewer

Company: Triaga, Inc.
Location: Wilson
Posted on: November 18, 2021

Job Description:

Batch Record Reviewer - Triaga Inc. Be part of a revolutionary change at a Fortune 500 company. At Triaga we've chosen to do something incredible. We're building our future on smoke free products with the power to change the lives of millions of smokers. With this start up initiative come huge opportunities. So, when ---you join us, you'll enjoy the freedom to dream up and deliver better, brighter solutions and the space to move your career forward in endlessly different directions. It's so rare in R&D that everything aligns to create the ideal conditions for outstanding work. Right now, at Triaga, that's exactly what's happening. By joining our strong Quality/R&D team, you will have the resources, support and technology you need to break new ground and see ideas come to life. You'll be surrounded by some of the brightest scientists in their fields, backed by extensive investment in R&D, and with fast access to subject matter experts and commercial decision makers. Your 'day to day': As Batch Record Reviewer you will be part of our Quality Department at Triaga Inc., and will be reporting to the Supervisor Manufacturing Quality. The position will be based in Wilson, NC. Ensure all relevant standards are respected along the manufacturing process and provide support to Quality and Production teams to analyze nonconformities and to identify improvement opportunities. Perform critical review of executed batch production records while managing intermediate and finished product non conformities and related corrective and preventive actions held and ultimately confirms to the final approver that the product can be released for commercial manufacturing. Provide reports and technical support to relevant departments related to quality performance and assessment of the product quality in line with QMS procedures. Your Responsibilities:

  • Provide Quality support and expertise in order to improve products and Quality systems and ensure timely quality support in case of any quality problems encountered on products, providing quality risk assessment and an accurate action plan/solution that immediately reduces the negative impact on the Quality and production KPI's.
  • Provide on floor support in the implementation of quality standard and self-control system in order to ensure that the products and the processes meet the quality requirements all along the manufacturing line.
  • Provide support on report generation and data analysis, when required by ensuring the compliance and integrity of data.
  • Establish a system to identify and segregate all non-conforming intermediate and finished products whether identified at warehouse, at laboratory, on the floor or post production. Investigate and resolve critical deviations, define disposal actions and when appropriate corrective actions.
  • Define and implement a monitoring system of manufactured products through appropriate historical data and trend analysis to identify potential deviations and preventive actions (CAPA).
  • Support the manufacturing team in the establishment and revision of the batch documentation, providing guidance on data and record management. Ensure manufacturing batch Record and Batch release documentation is accurate, complete, reviewed and archived in line with TRIAGA INC. guideline and QMS requirements to ensure confirmation that the product can be released for commercial manufacturing.
  • Provide support during product and process improvement test and new platform development. Support Quality Engineers to define new quality standards for new products.
  • Promote and apply all rules concerning TRIAGA INC. Quality, environment, health and safety. Who we're looking for:
    • University degree in Chemistry, Biological sciences, Physical sciences, Engineering or equivalent skills through demonstrated experience
    • At least 1 year experience in quality assurance or manufacturing in food, pharmaceutical or similar industry
    • Fluent in English both written and spoken What we offer:
      • Attractive salary and excellent benefits package: including 401(k) plan, Medical, Dental, and Vision coverage along with paid holidays and three weeks of vacation Our success depends on the men and women who come to work every single day with a sense of purpose and an appetite for progress. Join Triaga Inc. and you too can:
        • Seize the freedom to define your future and ours. We'll empower you to take risks, experiment and explore.
        • Be part of an inclusive, diverse culture, where everyone's contribution is respected; collaborate with some of the world's best people and feel like you belong.
        • Pursue your ambitions and develop your skills with a global business - our staggering size and scale provides endless opportunities to progress. #ZR

Keywords: Triaga, Inc., Wilson , Batch Record Reviewer, Other , Wilson, North Carolina

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