Document Control Specialist

2 days ago


Boston, Massachusetts, United States Messina Talent Advisors Full time
Job Title: Document Specialist

We are seeking a highly organized and detail-oriented Document Specialist to join our team at Messina Talent Advisors. As a key member of our laboratory operations team, you will be responsible for managing, organizing, and ensuring the accuracy and compliance of all laboratory documents.

Key Responsibilities:
  • Develop, revise, and maintain laboratory documents, including SOPs, policies, procedures, and work instructions for quality and compliance within our eQMS.
  • Ensure all documents are current, properly formatted, and in compliance with CLIA, CAP regulations, and other applicable standards.
  • Assist in preparing and maintaining documentation for CLIA inspections, CAP accreditation processes, and other regulatory audits.
  • Track and report on the status of document control activities, including updates and compliance.
  • Identify opportunities for process improvements in document management and control.
  • Provide leadership and serve as a resource to staff regarding CLIA, CAP, and related regulations and best practices.
Qualifications:
  • Bachelor of Science degree in medical technology, laboratory sciences, or a related scientific discipline.
  • Minimum of 5 years of Quality Assurance experience in a lab setting or related industry.
  • Knowledge and application of CLIA and CAP regulations are required.
Preferred Qualifications:
  • Demonstrated ability to work independently, exercise good judgment, and collaborate within an interdisciplinary team.
  • Excellent problem-solving and delegation skills, with demonstrated leadership ability.
  • Experience with ENSUR eQMS is preferred.
  • Experience with LIS software and knowledge of LIS documentation requirements.
  • Knowledge of GLP is preferred.
  • Experience in the medical device or in vitro diagnostics industry is a plus.
  • Certification in document control or quality management is a plus, but not required.
Company Description:

Messina Talent Advisors is a leading talent practice that has continuously evolved to meet the needs of our clients. We help our clients fill roles and build their teams, while also developing strategic talent initiatives that drive value for their organizations.



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