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Merz North America, Inc

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Applications Quality Engineer (Biotech)



About Us

Founded in 1908, Merz is a successful, family-owned specialty healthcare company with a rich history. As a leading global aesthetics business, our award-winning portfolio of injectables, devices, and skincare products empowers healthcare professionals to enhance confidence through aesthetic medicine. Our purpose is to fuel confidence by helping people look better, feel better, and live better. We believe you do not have to choose between living life and making a living. Live your best life with Merz Aesthetics.

 
A Brief Overview

Responsible for supporting the development, implementation, and maintenance of Quality System applications and data visualization tools. This role supports the development, implementation, and optimization of digital solutions that enhance operational excellence across quality and manufacturing processes. This role will provide support of applicable business applications and data visualization tools.

 

What You Will Do
  • Application Support and Management Provide application support by managing user accounts, permissions, and security policies Provide technical assistance to users as required. Troubleshoot issues and conduct training on new features and system use. Support the handling of incidents until they are fully resolved, with a detailed analysis of the underlying causes provided.
  • Application Development Configure and / or partner with internal or external design engineers to configure applications which align with business requirements. Support the principal designer for major systems and their subsystems.
  • System Improvements Collaborate with key stakeholder to support system upgrades and enhancements. Follow robust and validated processes for making changes.
  • System Validation Support or execute planning, development, and implementation of computer systems validation documentation and ensure compliance with required GxP and 21 CFR Part 11 regulations.
  • SOP Maintenance / Support Provide input in creation and/or review of internal operating procedures.
  • Compliance to Regulatory Requirements Assist in ensuring applicability of current quality policies, procedures and objectives by keeping informed of the latest updates/modifications related to industry standards and federal regulations.
  • Further Tasks Build relationships with end users and provide a positive working experience.
Minimum Requirements

  • Bachelor's Degree in Computer Science and/or Life Sciences.
  • 2+ years Medical Device or Pharmaceutical Manufacturing and/or other regulated industry or similar experience.
Technical & Functional Skills

  • Must be proficient in MS Word, Excel, and PowerPoint software programs. Required
  • Must have excellent verbal and written communication skills and leadership skills.
  • Ability to work with company staff and communicate effectively throughout the organization is essential.
  • Familiar with industry standards and Federal Regulations
  • Strong understanding of industry standards and best practices for computer validation such as GAMP 5, 21 CFR Part 11, Annex 11, etc.
  • Experience in application configuration.
  • Strong technical writing and general problem-solving skills.

Equal Opportunity Employer/Protected Veterans/Individuals with Disabilities
This employer is required to notify all applicants of their rights pursuant to federal employment laws. For further information, please review the Know Your Rights notice from the Department of Labor. Quality Systems/Customer Satisfaction

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