Senior Lab Supervisor - Compass Consulting

Our client develops, manufactures and supplies a wide array of innovative medical diagnostic products, services, tests, platforms and technologies.

Responsibilities:

• 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.
• 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 non 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.

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.