Regulatory Compliance Laboratory Manager

1 day ago


Santa Clara, California, United States Nesco Resource Full time

Job Summary:

A Senior Lab Supervisor position is available at Nesco Resource, overseeing the operations of research and development laboratories. The ideal candidate will ensure safety, compliance, and smooth operations within the team.

Key Responsibilities:

  • Process Development and Management: Develop or revise comprehensive documentation that meets organizational standards by writing user-friendly content. Review, revise, consolidate, and/or retire documents to align with QMS, local procedures, and/or best practices.
  • Laboratory Operations and Maintenance: Manage laboratory areas regarding general lab operations, regulatory compliance, and safety operations. Enforce safety practices, with authority to deny room access and impose re-orientation if necessary.
  • Documentation and Quality Control: Ensure quality, safety, and departmental compliance in lab documentation. Review equipment/instrumentation documentation for Good Documentation Practices.
  • Collaboration and Communication: Act as a point of contact with department scientific staff and cross-functionally with Subject Matter Experts in Calibration/Facilities to minimize impact on project teams during equipment installation and validation.
  • Calibration and Repair Coordination: Coordinate calibration, certification, relocation, and repair of existing equipment with Instrument/Facilities/Calibration team.
  • Ongoing Training and Support: Mentor/coach other Lab Supervisors, provide training, and develop skills.

Requirements:

  • Bachelor's Degree in Biological/Life Sciences, Chemistry, Biochemistry, or related field, or equivalent combination of education and work-experience.
  • 3-4 years Relevant industry experience working in an IVD GLP/ISO regulated laboratory environment.
  • Strong people skills with ability to collaborate and build effective internal/cross-functional relationships.
  • Excellent written and verbal communication skills.
  • Diligent attention to detail and willingness to take on new challenges.

Compensation:

The estimated salary for this position is $95,000 - $115,000 per annum, depending on location and experience.



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