STARLIMS

Manager – Quality and Regulatory Affairs

STARLIMS

full-time

Posted on:

Location Type: Remote

Location: Remote • 🇺🇸 United States

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Job Level

Mid-LevelSenior

About the role

  • Administrative Support – scheduling meetings, preparing reports, and maintaining audit and CAPA schedules.
  • Audit Support – prepare for internal and external quality audits by organizing documentation and ensuring compliance with relevant standards (ISO 9001 and ISO 27001) and HIPAA and GDPR regulations.
  • Process Support – Assist in implementing and monitoring quality processes and systems to ensure they meet organizational standards and objectives.
  • Training and Compliance - Manage internal employee training in the STARlearn (LITMOS) system, provide data on training completion rates, create training modules as needed, and ensure training is completed promptly.
  • Data Collection and Analysis – Gather and organize quality-related data to support internal audits, management reviews, and continual improvement efforts.
  • Continual Improvement – participate in projects aimed at improving the efficiency and effectiveness of the quality and information security management systems.

Requirements

  • 5 -10 years of experience working with ISO 9001:2015 and ISO 27001:2022 standards, either as an internal or external auditor or Quality Assistant.
  • Certification with ASQ or Exemplar Global is a plus.
  • Self–starter – must be able to work with minimal supervision, pro-active, open to new concepts, and engage with others without prompting.
  • Attention to Detail – must be meticulous in work approach to ensure accurate record-keeping and quality control.
  • Organizational Skills – Must be able to manage multiple tasks, documents, and projects without reminders.
  • Computer Proficiency – MS Office Suite, SharePoint, Salesforce, LITMOS LIMS, Zendesk.
  • Problem solving – must be able to identify minor issues and contribute to finding solutions.
Benefits
  • Competitive health and Wellness (medical, dental, and vision)
  • Retirement plan with matching company contribution
  • Life Insurance and Disability/Income Protection

Applicant Tracking System Keywords

Tip: use these terms in your resume and cover letter to boost ATS matches.

Hard skills
ISO 9001ISO 27001quality auditsdata analysisquality processestraining module creationcompliance monitoringaudit documentationquality controlprocess improvement
Soft skills
attention to detailorganizational skillsproblem solvingself-starterproactiveengagementmeticulousnessmulti-taskingcommunicationadaptability
Certifications
ASQ certificationExemplar Global certification
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