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Quality Assurance Manager

This position manages quality assurance in a diverse and expanding research organization. The Quality Assurance Manager will ensure compliance to regulatory or other standards such as Good Clinical Practice (GCP), Good Laboratory Practice (GLP), Good Manufacturing Practice (GMP) or ISO 17025 as appropriate for the study or project. The quality manager is responsible for ensuring a strong quality system is maintained. The quality manager ensures processes are in place that assure clients that RTI’s testing and study work is accurate and performed in compliance with RTI processes and any relevant regulatory or sponsor requirements. The quality manger will work closely with clinical and lab management to ensure RTI maintains a high level of quality and traceability. This position reports to the CEO.

Primary Job Functions:

· Ensure RTI operates at a high level of quality and that any regulatory, sponsor, or RTI internal requirements are met for each study, project, or test.

· Perform internal audits and phase inspections and coordinate any corrective actions that result.

· Maintain the Corrective and Preventive Action system.

· Maintain the Master Schedule and manage the archives.

· Manage the Standard Operating Procedure (SOP) and Data Capture Form (DCF) system.

· Ensure 100% study data review occurs and assist with study binder preparation and post-study copying and shipping.

· Help develop procedures to implement applicable quality and regulatory requirements (USDA, FDA, GLP, GMP, ISO 17025) and work with clinical and lab teams to develop SOPs or DCFs for new processes.

· Maintain employee training records.

· Perform quality orientation and quality trainings to staff throughout the year as needed.

· Provide expertise to clinical and lab teams on quality requirements.

· Lead problem solving, troubleshooting, and corrective action activities in quality related areas.

· Work with clinical research and laboratory teams to meet operational goals.

· Ensure confidentiality of client and company information.

Required Skills:

· Ability to work in a fast paced environment. Must be able to adjust to changing priorities and a dynamic work environment.

· Robust knowledge of quality system requirements.

· Experience with one of more quality regulations such as GCP, GLP, GMP, and/or ISO 17025.

· Ability to make critical decisions and work independently, often under time-sensitive situations, within a team environment.

· Ability to communicate with all levels of personnel, clients, and regulatory authorities.

· Commitment to teamwork and to over delivering on client satisfaction.

· Excellent written and verbal skills.

Education and Experience

· Bachelor’s Degree in biological science or microbiology.

· Minimum 4 years’ experience in positions of increasing responsibility with at least 2 years of quality management experience.

Job Type: Full-time

 

Clinical Research Veterinarian

Research Laboratory Scientist

Primary Job Functions:

  • Plan, organize, and conduct assay development, experimental methodologies, biological testing and a wide assortment of research projects as specified by client and project needs.
  • Develop innovative ideas and business practices for all RTI scientific, laboratory tasks, and RTI operations.
  • Write SOPs and create quality record keeping data forms appropriate for the type of work.
  • Report writing, experimental summarizations of project and testing work in a professional and complete manner.
  • Identify and lead problem solving and troubleshooting efforts related to project or testing work.
  • Assist with budgeting and implementing of new methods to expand laboratory capabilities.
  • Participate in cross-training efforts within both diagnostic and research laboratories to maintain competence in the overall core RTI lab procedures.
  • Assist with the laboratory maintenance activities, maintain a clean and organized laboratory space and ensure supplies remain stocked as needed.
  • Rotation of weekend and holiday coverage with co-workers.

Required Skills

  • Passion for science, goal driven, commitment to safety, client service, and high quality.
  • Ability to manage projects in a fast paced laboratory environment.  Must be able to adapt to changing priorities and a dynamic work environment.
  • Ability to meet deadlines while maintaining a high level of quality.
  • Experienced in molecular biology, ELISA development and PCR development/validations, gel electrophoresis, vaccine and master seed cell culture development, monoclonal antibody production and recombinant bioprocessing, immunologic, viral or bacteriologic assays and growth.
  • Experience with microbiological quality control procedures under GLP, cGMP, and/or ISO 17025 regulations.
  • Strong time management skills with the ability to prioritize and maintain progress on multiple tasks.
  • Excellent written, oral and interpersonal communication skills with a behavioral demeanor for teamwork and unity with colleagues.
  • Meticulous attention to detail and accuracy.

Education and Experience

  • Bachelor’s Degree in biological sciences, virology, immunology, microbiology, molecular biology or cellular physiology.  Master’s Degree preferred.
  • Minimum 5 years’ experience in positions of increasing responsibility with proven project management experience preferred.

Work Status:

  • Full time.

Diagnostic Laboratory Scientist

Primary Job Functions:

  • Perform sample processing and testing to written specifications and to meet established deadlines.
  • Develop innovative ideas and business practices for all RTI laboratory tasks, and RTI operations.
  • Perform equipment maintenance, calibration, verification and assist with lab sanitation.
  • Document validation, calibration, and testing work on established forms and create spreadsheets and reports summarizing testing results.
  • Write SOPs and create record keeping data forms to ensure complete record keeping as appropriate for the type of work being performed.
  • Identify and lead problem solving and troubleshooting efforts related to project or testing work.
  • Participate in cross-training efforts within both diagnostic and research laboratories to maintain competence in the overall core RTI lab procedures.
  • Assist with the laboratory maintenance activities, maintain a clean and organized laboratory space and ensure supplies remain stocked as needed.
  • Rotation of weekend and holiday coverage with co-workers.

Required Skills

  • Passion for science, goal driven, commitment to safety, client service, and high quality.
  • Ability to manage assays in a fast paced laboratory environment.  Must be able to adapt to changing priorities and a dynamic work environment.
  • Experience with microbiological quality control procedures under GLP, cGMP, and/or ISO 17025 regulations is a plus.
  • Ability to work independently, often under time-sensitive situations, within a team environment.
  • Experience working in laboratory environment and knowledge of basic microbiology processes.
  • Excellent written, oral and interpersonal communication skills with a behavioral demeanor for teamwork and unity with colleagues.
  • Meticulous attention to detail and accuracy.

Education and Experience

  • Bachelor’s Degree in biological science or microbiology.

Work Status:

  • Full time.
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