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Document Control Analyst

Document Control Analyst

Bausch & Lomb GmbHGreenville, SC, US
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Overview

Bausch + Lomb (NYSE / TSX : BLCO) is a leading global eye health company dedicated to protecting and enhancing the gift of sight for millions of people around the world—from the moment of birth through every phase of life. Our mission is simple, yet powerful : helping you see better, to live better.

Our comprehensive portfolio of over 400 products is fully integrated and built to serve our customers across the full spectrum of their eye health needs throughout their lives. Our iconic brand is built on the deep trust and loyalty of our customers established over our 170-year history. We have a significant global research, development, manufacturing and commercial footprint of approximately 13,000 employees and a presence in approximately 100 countries, extending our reach to billions of potential customers across the globe. We have long been associated with many of the most significant advances in eye health, and we believe we are well positioned to continue leading the advancement of eye health in the future.

Purpose of Job :

Reporting directly to the Manufacturing Quality Assurance Supervisor, the MQA Line Inspector is responsible for performing Quality inspections for finished goods & contract goods associated with products manufactured & distributed by B+L Greenville. These inspections require the use of statistical sampling plans to conduct visual and functional inspections to determine compliance with cGMP's, local / regional SOP's, and associated regulations. In addition to inspection requirements, this position will provide guidance for issue resolution, product containment, and non-conformance generation if necessary. This position is also responsible for completing the audit and release of Lot History Records for sterilized components, packaged solutions, accessories, and contract finished goods.

Responsibilities

INSPECTION :

  • Utilizes statistical sampling plans to perform visual and functional inspections of contract and Greenville finished product. Documents all results in the QA batch record or on the Receiving Inspection Report. Assists in quality decisions for nonconforming product and provides QA inspection support to the Manufacturing operation.
  • Assists in the Investigation and documentation of process issues that occur during the production operation including input to in-process product quality decisions.
  • Maintains retain sample inventory for all finished product.

AUDITING and PRODUCT RELEASE—

  • The audit and release of all Lot History Records associated with finished product release must be completed in a timely manner.
  • These records consist of the following : Sterilization Cycles (conducted by Steam, Gamma Irradiation, and Ethylene Oxide exposure).
  • Accessory Manufacturing (Packaging and QA).
  • Qualifications

    Experience :

  • 2-3 years prior manufacturing or inspection experience required
  • Prior exposure to visual and dimensional inspection required
  • Previous inspection experience using balances and dimensional tools preferred.
  • Specialized Skills :

  • Warehouse Management System (ERPLX) and Document Management System (Documentum).
  • Excellent written and verbal communication skills demonstrated. Good people skills. Must be able to communicate with a cross functional team and management concerning quality issues.
  • Decision-making ability and ability to work unsupervised expected.
  • QA background is preferred. Previous experience with the batch record release process is preferred.
  • This position may be available in the following location : Greenville, SC

    All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or veteran status.

    Job Applicants should be aware of job offer scams perpetrated through the use of the Internet and social media platforms. Applicants must be authorized to work for ANY employer in the U.S. We are unable to sponsor or take over sponsorship of an employment Visa at this time.

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    Document Control • Greenville, SC, US

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