QA Computerized Systems Coordinator

Opella•Chattanooga, TN
•$51,000 - $73,667

About The Position

The QA Computerized Systems Coordinator serves as the Chattanooga site administrator for quality and laboratory computerized systems. The role oversees system configurations, routine updates, master data maintenance, and data governance, while supporting the site's computerized systems validation program to keep systems compliant, effective, and aligned with quality and regulatory requirements. The coordinator establishes and maintains master data standards and governance, administers laboratory and quality systems, and supports data validation, audits, training, troubleshooting, and system changes. The role also coordinates data synchronization across enterprise platforms and acts as the site subject matter expert and liaison for computerized systems validation and global system support. Opella describes its broader mission as making self-care simpler and putting health in people's hands. The company emphasizes sustainability, access, social impact, diversity, belonging, and collaboration.

Requirements

  • Bachelor’s degree in Science, Engineering, Computer Science, or a related field preferred.
  • At least 5 years of experience in QC laboratory testing and computerized systems.
  • Hands-on experience with SAP.
  • Strong proficiency in Microsoft Office applications, including Excel, Word, and Outlook.
  • Strong knowledge of QC testing procedures, laboratory practices, and Good Documentation Practices (GDP).
  • Experience supporting computerized systems validation (CSV) activities and maintaining compliance within regulated environments.
  • Excellent attention to detail and interpersonal skills.
  • Ability to multitask, adapt to changing priorities, and work effectively with cross-functional teams.

Nice To Haves

  • Bachelor’s degree in Science, Engineering, Computer Science, or a related field is preferred.

Responsibilities

  • Establish and maintain master data standards, governance policies, and procedures to ensure data accuracy, consistency, and compliance.
  • Administer and support quality and laboratory systems, including configuration and maintenance of samples, tests, methods, instruments, and location data.
  • Implement data validation rules, perform data quality audits, and ensure master data meets regulatory and quality requirements.
  • Provide user training, troubleshooting, and ongoing support for computerized systems and data management processes.
  • Lead change management activities for local and global system enhancements, upgrades, and integrations, and serve as the site liaison for global support teams.
  • Coordinate master data synchronization across connected systems, including ERP, QMS, and other enterprise platforms.
  • Act as the site subject matter expert for computerized systems validation, oversee validation activities, and support master data and quality assurance projects as needed.
  • Serve as the Chattanooga site administrator for quality and laboratory computerized systems, overseeing configurations, routine updates, master data maintenance, and data governance.
  • Support the site's computerized systems validation program to ensure systems remain compliant, effective, and aligned with quality and regulatory requirements.
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