Laboratory Quality Manager

Sapient

Biomarker discovery at unprecedented speed & scale

https://sapient.bio 858.290.7010

Reporting directly to the Laboratory Director, the Laboratory Quality Manager will collaborate with a dedicated team of laboratory personnel, IT, and operations to drive compliance with laboratory quality and regulatory requirements.

Responsibilities

  • Maintain the quality management system and document control system

  • Ensure that current quality management program complies with relevant regulatory requirements

  • Assist in generation of testing documentation and records (validation, quality control, etc…)

  • Train staff as needed

  • Collaborate with other departments to address issues and meet deadlines

  • Support inspection and audit activities

  • Assist in the integration of environmental health, safety, and security into the business processes

  • Ability to anticipate problems before they become critical and involve management when appropriate

Qualifications

  • Bachelor’s degree in a STEM field, ideally with mass spectrometry background

  • A minimum of 2-5 years of professional experience working in a CLIA or GLP regulated lab with a focus on, but not limited to, small molecule analysis

  • Experience with GLP and FDA bioanalytical regulatory requirements

Tagged as: clia, continuous improvement, document management, GLP, good laboratory practice, laboratory skills, mass spectrometry, quality management, quality system, regulatory requirements, staff training

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