Senior GCLP Quality Assurance Specialist

3 weeks ago


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

Job Overview:

The BioSpace, Inc. is seeking a highly skilled and experienced Senior GCLP Quality Assurance Specialist to lead and support laboratory quality activities.

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
  • Evaluate and monitor 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:

  • 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
  • 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

Estimated Salary: $74,800 - $128,625 per annum.



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