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Senior Lab Supervisor

Santa Clara, CA 95050

Posted: 11/12/2024 Employment Type: Contract Job Category: Scientific Job Number: 615769 Is job remote?: No Country: United States

Job Description


Target Pay Rate: 39-50/hr **salary will be commensurate with experience 

Job Description:


Ensures the safety, compliance, and smooth operations of research and development laboratories associated with the team. Regulates and maintains the infrastructure of the labs to ensure necessary services are available to scientists.
Oversees/coordinates work processes and operation of assigned laboratory areas to ensure Quality System compliance, Safety compliance, and proper equipment management. Ensures decisions involving Research and Development labs and equipment do not adversely impact work areas or project teams. Represents Lab Management team as a subject matter expert regarding lab/equipment issues and builds professional relationships with cross-functional teams. Communicates with lab and equipment users and process stakeholders.

Responsibilities:
  • Generates or modifies Development Laboratory Management related processes (e.g., Guidance Documents, SOPs). Develop or revise comprehensive documentation that meets organizational standards by writing user-friendly content that meets the needs of target audience, turning insights into language for user success. Review, revise, consolidate and/or retire documents to align with QMS, local procedures and/or best practices.
  • Reviews revisions to existing procedures or new draft procedures with stakeholders, including Quality, and facilitates a Change Request (if needed)
  • Manages, oversees, and authorizes the use of designated laboratory areas with regard to general lab operations (orientation, use, access, general supply replenishment, equipment, cleaning, & maintenance), regulatory compliance (documentation, temperature monitoring) and general safety operations.
  • Enforces Safety and other required laboratory practices, with the independent authority to deny lab users room access, impose re-orientation, and contact users supervisor if necessary. Mediates Lab User conflicts with the authority to escalate issues to direct supervisors.
  • Manages lab documentation to ensure Quality, Safety and departmental compliance. Reviews and ensures equipment/instrumentation documentation (log sheets, chart recorders) is compliant with Good Documentation Practices.
  • Resolves documentation issues with equipment users.
  • Acts and serves as point of contact with department scientific staff and cross-functionally with Subject Matter Experts in Calibration/Facilities to ensure minimal impact to Development project teams during installation, calibration and validation of new nonclient branded equipment.
  • Coordinates calibration, certification, relocation and repair of existing equipment with Instrument /Facilities/Calibration team to minimize impact on project teams needing access to equipment.
  • Participates in a weekly rotating 27/4 on-call CTU service (when alerted for a temperature excursion) with the other Lab Supervisors. Responsibilities include inhibiting alarms in the CTU monitoring software and coming on-site to relocate contents from the failing CTU to a back-up CTU within the allowable timeframe (2 hours or 5 hours) for the type of CTU.
  • Mentors/coaches other Lab Supervisors, provides training and seeks opportunities to develop skills.
  • Other duties as assigned by management.

Education:

Bachelor's Degree - Biological/Life Sciences, Chemistry, Biochemistry or related field, or equivalent combination of education and work-experience.

Experience:

3-4 years Relevant industry experience working in an IVD GLP/ISO regulated laboratory environment. (required) 5+ years Relevant industry experience. Experience in audits, knowledgeable in requirements and controls for IVD product development lab, (e.g. ISO 13485, GLP, GDP) or similar regulated lab environment. (preferred)

Knowledge, Skill or Ability Requirements:
  • Possesses excellent people skills with ability to collaborate and build effective internal/cross-functional relationships.
  • Strong desire to work in a highly regulated environment, with diligent attention to detail to ensure Development laboratory areas meet regulatory, departmental, and safety requirements.
  • Willingness to take on new challenges, perform additional tasks when necessary, and work at other RSS sites if necessary to meet Research & Development needs and support business goals.
  • Experience as an effective technical writer with a proven ability to quickly learn and understand complex subject matter with a keen eye for detail. Experience in writing and/or revising documentation and procedures for various audiences. Excellent written and verbal communication skills.
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About Santa Clara, CA

Ready to take the next step in your career? Explore our job opportunities in the vibrant area around Santa Clara, California. Located in the heart of Silicon Valley, this region offers unparalleled growth opportunities in tech, innovation, and beyond. With attractions like Levi's Stadium, the Santa Clara Convention Center, and the nearby California's Great America theme park, there's always something exciting to do. Indulge in the diverse culinary scene, catch a show at the Triton Museum of Art or the historic Santa Clara Theatre, or cheer for the San Francisco 49ers at Levi's Stadium. Discover why Santa Clara is the perfect place to elevate your career and enjoy a rich blend of culture and charm!

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