Lead GCLP Quality Assurance Specialist

4 weeks ago

Frederick, Maryland, United States BioSpace, Inc. Full time

Job Summary

The Frederick National Laboratory is seeking a seasoned Quality Assurance professional to lead and support laboratory quality activities. The ideal candidate will have strong knowledge in GCLP and experience in quality control and quality assurance related to immunology, virology, and/or molecular biology procedures.

Key Responsibilities

  • Lead continuous performance evaluation of internal controls, communications, risk assessments, and maintenance of documentation, including SOPs, as related to compliance with internal and external safety, quality, and regulatory standards for GCLP.
  • Evaluation and monitoring of conformance to established quality assurance processes and standards for testing and laboratory practices.
  • Identify risk and evaluate deficiencies and deviations in a routine basis while working with internal departments/business units to appropriately remedy them.
  • Develop appropriate risk management strategies.
  • Assist staff with the creation, implementation, and follow-up of Corrective and Preventive Actions.
  • Implement and develop appropriate Corrective and Preventive Actions Program in collaboration with VICD management/leadership.
  • Work with laboratory director and manager to plan, qualify, verify, and validate tests/assays and equipment.
  • Working closely with the laboratory to write SOPs and Quality Assurance plans appropriate for each group.
  • Participate in the review and revision of standard operating procedures to adhere to regulatory regulations.
  • Working closely with appropriate staff, prepare standard operating procedures for quality control activities.
  • Review documents for content, accuracy, and compliance.
  • Develop and monitor quality assurance standards.
  • Prepare guidance documents.
  • Review records, test results, and data for completeness, accuracy, and compliance with specifications and requirements.
  • Facilitate internal training and quality assurance requirements, processes, and procedures, and maintain training records for staff.
  • Maintain document control system and ensure version control for all standard operating procedures.
  • Lead and perform internal audits, identify deficiencies, recommend improvements, and make risk assessments.
  • Implement training programs for laboratory personnel on quality assurance requirements, processes, and procedures.
  • Ensure compliance with SOPs, GCLP/CLIA regulations, and FDA as applicable.

Requirements

  • Possession of Bachelor's degree from an accredited college/university according to the Council for Higher Education Accreditation (CHEA) or four (4) years relevant experience in lieu of degree.
  • Foreign degrees must be evaluated for U.S. equivalency.
  • In addition to the education requirement, a minimum of eight (8) years of experience working in GCLP or GLP environment.
  • Trained in GCLP or GLP.
  • Excellent communication, organization, and writing skills.
  • Ability to obtain and maintain a security clearance.

Preferred Qualifications

  • Experience in quality control and quality assurance related to immunology, virology, and/or molecular biology procedures for reagent production and assay development and performance.
  • Strong understanding of regulatory and GCLP/CLIA requirements.
  • Experience working with standards and reference materials, immune assay (ELISA, multiplex assays) development and validation.

Job Hazards

This position is subject to working with or have potential for exposure to infectious material, requiring medical clearance and immunizations.

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