Senior Quality Assurance Analyst

Qualifications

• Education:
  • Bachelor’s degree in life sciences or related field from an accredited college or university
  • Master’s degree in business or life sciences or related field preferred
• Experience:
  • Five years clinical research or equivalent experience
  • Three years in Quality Assurance or Regulatory Compliance experience within an FDA regulated industry, preferably devices, diagnostics, or pharmaceuticals desirable
  • Training experience in a clinical research setting
  • Regulatory audit exposure with US-FDA preferred

Skills and Abilities

• Demonstrates the skills and competencies necessary to safely perform the assigned job
• Sufficient proficiency in speaking, reading, and writing the English language
• Excellent working knowledge of FDA regulations and GCP guidelines
• Excellent working knowledge of the clinical trial operations
• Ability to identify and/or resolve quality issues/discrepancies with others
• Ability to work in a team environment with effective leadership skills

Essential Functions

People Essential Functions

• Facilitates open, professional communication
• Provides higher-level support to institutional investigators and other members of the research team
• Serves as a subject matter expert and regulatory resource
• Teaches, orients, and precepts, as appropriate, newly hired analysts
• Uses peer-to-peer accountability towards improvement of department score for employee engagement

Service Essential Functions

• Assists in identifying educational needs and creating/implementing training courses or materials
• Assists Research Protections staff and HMRI administration, as needed
• Evaluates site readiness based on HMRI standards prior to start date of a new clinical trial

Quality/Safety Essential Functions

• Performs and monitors feasibility assessments
• Makes ongoing quality assurance reviews of pre-clinical and clinical research studies
• Monitors and evaluates ongoing quality and compliance standards
• Initiates goals and creates targets for Monitoring Assessment plans (MAPS)
• Utilizes sound judgement, uses an analytical approach, ensures implementation and teaching of department-based initiatives and standards of practice, identifies trends and opportunities for corrective action and process improvement, provides recommendations

Finance Essential Functions

• Initiates cost saving ideas within the department
• Utilizes resources with cost effectiveness and value creation in mind
• Self-motivated to independently manage time effectively and prioritize daily tasks, assists coworkers as needed

Growth/Innovation Essential Functions

• Independently evaluates responses to monitoring and audit reports
• Presents areas for innovation, efficiency, and improvement for department projects
• Seeks opportunities to identify self-development needs and takes appropriate action
• Ensures own career discussions occur with appropriate management
• Completes and updates the My Development Plan on an ongoing basis

Supplemental Requirements

• Work Attire: Business professional, uniform, scrubs, or other (department approved)
• On Call*: No
• May require travel within the Houston Metropolitan area: Yes
• May require travel outside Houston Metropolitan area: No

Company Profile

Houston Methodist Academic Institute oversees the Education Institute and Research Institute. The Academic Institute aligns our research and education initiatives in service to the clinical mission, providing solutions that answer the call for new technologies and skills our clinicians need for patient care. Houston Methodist Education Institute coordinates our primary academic affiliation with Weill Cornell Medicine and other joint programs, including the Engineering Medicine Program at Texas A&M University Intercollegiate School of Engineering Medicine. The Education Institute also oversees continuing medical education and graduate medical education, and supports trainees in residence for medical, nursing, allied health and research education programs. Houston Methodist Research Institute supports research programs and infrastructure that enable faculty across the system to bring new scientific discoveries to patients as rapidly as possible through the full cycle of a cure from conceptual bench research, to prototyping and development, to clinical trials and FDA approval. The Research Institute supports clinical research protocols and extramurally funded translational research programs.

Houston Methodist is an Equal Opportunity Employer.