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Study Director

3 months ago

San Francisco, California, United States Sotera Health Services, LLC Full time
Job Description

Job Summary:

The Study Director - Filters has overall responsibility for the technical conduct of all assigned tests as well as for the review, interpretation, analysis, documentation, and reporting of results. The study director is the single point of study control. The study director ensures all assigned studies are completed on time.

Education requirements:
  • B.S. degree in a Relevant Life Science
Experience/Skill Requirements:
  • 2+ years' experience executing and overseeing filtration laboratory testing procedures
  • General skills
    • Ability to troubleshoot, identifying and resolving issues
    • Works well under pressure
    • Enjoys fast-paced environment
    • Ability to efficiently plan and manage test schedule
    • Ability to manage inventory
    • Attention to detail with reading instructions
    • Attention to detail with documentation
    • Prioritization of tasks to meet deadlines
    • Knowledge of safe handling and storage of chemicals
    • Collaboration with other team members
  • Area-specific skills
    • Experience with filter housings
    • Bubble point testing
    • Automated integrity tester experience
    • Aseptic technique
    • Ability to operate and maintain lab equipment
Essential Duties:

Scientific/General
  • Ensure reports are compliant with current procedures; reflecting the data, results, and conclusions of the testing.
  • Ensure sample and data traceability are maintained throughout testing, calculations and statistics accurately reflect the raw data and test controls and monitors are accurately recorded and reviewed
  • Collaborate within the Quality Event (QE) process
  • Read and maintain an understanding of validation procedures
Regulatory Compliance
  • Know and follow applicable regulatory requirements (GMP, GLP, ISO, etc.).
  • Ensure that test procedures are approved, communicated to, and followed by analysts
Customer Service
  • Communicate regularly with external clients as needed to relay study updates
  • Meet or exceed sponsor expectations
  • Collaborate with the Sales department on testing quotes
  • Maintain a general understanding of company pricing and credit policies
  • Coordinate workflow to ensure client expectations are met
Competencies of this position

Technical
  • Knowledge of laboratory testing, equipment, procedures, and basic math sufficient to direct and oversee assigned testing
  • Ability to follow written procedures
  • Good documentation practice (GDP)
  • Effective critical thinking, problem-solving, and decision-making skills
  • Ability to learn and comprehend difficult tasks
  • Ability to troubleshoot problems
  • Attention to detail
  • Effective computer skills: Microsoft Office and laboratory systems
Professional
  • Effective communication skills: verbal, written, and active listening
  • Ability to organize and manage workload
  • Ability to meet deadlines
About Us

The name Sotera Health was inspired by Soteria, the Greek goddess of safety, and reflects the Company's unwavering commitment to its mission, Safeguarding Global Health. Sotera Health Company is a leading global provider of mission-critical sterilization and lab testing and advisory services for the healthcare industry. With a combined tenure across our businesses of nearly 200 years and our industry recognized scientific and technological expertise, we help to ensure the safety of millions of patients and healthcare practitioners around the world every year. Across our 64 facilities worldwide, we have over 3,000 employees who are dedicated to safety and quality. We are a trusted partner to more than 5,800 customers in over 50 countries, including more than 40 of the top 50 medical device companies and 8 of the top 10 global pharmaceutical companies.

Sotera Health goes to market through its three best-in-class businesses - Sterigenics, Nordion and Nelson Labs. Sterigenics is a leading global provider of outsourced terminal sterilization and irradiation services for the medical device, pharmaceutical, food safety and advanced applications markets. Nordion is the leading global provider of Co-60 and gamma irradiators, which are key components to the gamma sterilization process. Nelson Labs is a global leader in outsourced microbiological and analytical chemistry testing and advisory services for the medical device and pharmaceutical industries. Learn more about Sotera Health at

About the Team

Nelson Labs is a global leader in microbiological and analytical chemistry testing and advisory services for the medical device and pharmaceutical industries. Nelson Labs serves over 3,800 customers across 14 facilities in the United States, Mexico, Asia and Europe. We have a comprehensive array of over 800 laboratory tests supporting our customers from initial product development and sterilization validation, through regulatory approval and ongoing product testing for sterility, safety and quality assurance. We are regarded as a best-in-class partner with a strong track record of collaborating with customers to solve complex issues. Learn more about Nelson Labs at
Safeguarding Global Health - with every test we complete.