Manager of Quality and Regulatory Affairs

3 days ago

Remote, Oregon, United States Starlims Full time

STARLIMS provides leading Laboratory Information Management Systems (LIMS) solutions that have served customers around the world for over 30 years. STARLIMS solution suite helps to improve the reliability of laboratory sampling processes, manage complex testing workflows and analytical methods, support compliance with global regulatory requirements and industry standards, and provide comprehensive reporting, monitoring, and analysis capabilities. With multiple support centers across the globe in North America, EMEA and APAC, STARLIMS solutions are used in labs across multiple industries and disciplines including pharma & biotech, life sciences, food & beverage, manufacturing, petrochemical refineries and oil & gas, chemical, public health, forensics and environmental offering an influx of global career opportunities.

STARLIMS is looking for a Manager of Quality and Regulatory Affairs. This role requires that you have prior experience in the software industry.

Key Responsibilities:

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 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. Familiarity with all types of methods to collect data.

Continual Improvement – participate in projects aimed at improving the efficiency and effectiveness of the quality and information security management systems. Must have a close eye for trends and/or opportunities for improvement. Drive projects to completion.

Required Experience:

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.

*Occasional travel*

At STARLIMS we offer market competitive benefits such as:

  • Competitive health and Wellness (medical, dental, and vision)
  • Retirement plan with matching company contribution
  • Life Insurance and Disability/Income Protection

STARLIMS is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, creed, religion, color, national or ethnic origin, citizenship, sex, sexual orientation, gender identity and expression, genetic information, veteran status, age or disability status.

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