In addition to evaluating each candidate's relative ability, as demonstrated by quality and breadth of experience, the following factors will provide the basis for competitively evaluating each candidate:
Chemical or Microbiological Sciences
• A Ph.D. or equivalent in a relevant scientific field (e.g., biology, microbiology, chemistry, biomedical sciences, or related disciplines).
• Additional certifications or training in quality management systems for laboratory accreditation highly desired (e.g., CLIA and ISO/IEC 17025, Good Laboratory Practice (GLP), or Six Sigma).
• Several years of hands-on laboratory research experience, with a proven track record of scientific publications and contributions to the field.
• Demonstrated experience in Maintenance, Calibration and Measuring laboratory equipment.
• Experience with regulatory standards and compliance, including FDA, EPA, OSHA, and other relevant agencies.
• In-depth knowledge of scientific principles, laboratory techniques, and testing procedures.
• Proficiency in quality assurance methodologies, process improvement, and quality control.
• Strong understanding of regulatory requirements and standards applicable to laboratory operations.
• Excellent project management skills to oversee multiple laboratory programs and initiatives.
• Strong analytical and problem-solving skills to conduct root cause analysis and implement corrective actions.
• Effective verbal and written communication skills to coordinate with stakeholders, authors, and regulatory bodies, and to report findings and resolutions.
• Attention to detail for reviewing records, Standard Operating Procedures (SOPs), and ensuring compliance and effectiveness.
• Proficiency in drafting and reviewing technical documents, including SOPs, quality manuals, and regulatory reports.
• Ability to lead and inspire a team, fostering a culture of quality and continuous improvement and collaboration across laboratory programs.
• Strong interpersonal skills to work effectively with cross-functional teams and external partners.
• Flexibility to adapt to changing regulations, technologies, and scientific advancements.
• Commitment to maintaining high ethical standards and integrity in all research and quality assurance activities.
• Membership in professional organizations (e.g., American Society for Quality (ASQ), Association for the Advancement of Medical Instrumentation (AAMI)).
• Commitment to ongoing professional development and staying current with industry trends and regulatory changes.