Quality Assurance Manager

4 days ago

Portland, Oregon, United States Rose City Laboratories llc Full time
Job Summary

Rose City Laboratories is seeking a highly skilled Quality Assurance Officer to join our team. As a Quality Assurance Officer, you will be responsible for developing, implementing, and maintaining our quality management system (QMS) to ensure compliance with relevant regulatory standards, such as NELAC TNI and ISO/IEC 17025.

Key Responsibilities:

  • Develop and implement the laboratory's QMS, ensuring compliance with regulatory standards and industry best practices.
  • Maintain and update quality documentation, including SOPs, quality manuals, and records.
  • Plan, conduct, and report on internal audits to assess compliance with the QMS.
  • Help coordinate and manage external audits by regulatory bodies.
  • Follow up on audit findings, ensuring timely and effective corrective and preventive actions.
  • Train laboratory personnel on quality assurance practices and procedures, and maintain comprehensive training records.
  • Ensure all staff are aware of and comply with the QMS requirements.
  • Support continuous improvement by identifying training needs and opportunities.
  • Monitor laboratory data and records for accuracy, completeness, and compliance.
  • Ensure proper documentation and traceability of all testing activities.
  • Identify opportunities for improvement in laboratory processes and quality management.
  • Lead or participate in quality improvement initiatives, ensuring successful implementation.
  • Monitor and analyze quality metrics, reporting trends to senior management.

Qualifications:

  • Bachelor's degree in Chemistry, Biochemistry, Biology, or a related field.
  • Minimum of 3 years of experience in a quality assurance role within an analytical testing laboratory.
  • In-depth knowledge of quality management systems, particularly NELAC TNI and ISO/IEC 17025.
  • Strong understanding of laboratory procedures, regulatory requirements, and best practices.
  • Excellent attention to detail, organizational skills, and problem-solving abilities.
  • Strong communication and interpersonal skills, with the ability to work collaboratively with laboratory staff and management.
  • Experience with audit processes and managing corrective actions.
  • Experience with Promium (Clinisys) Element LIMS software and other office and laboratory computer applications.
  • Possess general knowledge of the analytical methods for which data review is performed.
  • Excellent time management skills with the ability to multi-task, effectively manage changing priorities, and remain calm under pressure.

Benefits:

  • Competitive salary based on experience.
  • Comprehensive benefits package, including health insurance, retirement plans, and paid time off.
  • Opportunities for professional development and career advancement.
  • A collaborative and supportive work environment.

Rose City Laboratories is an equal opportunity employer. We celebrate diversity and are committed to creating an inclusive environment for all employees.

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