Our client a world leader in diagnostics and life sciences is looking for a "Lab Supervisor".
Duration: Long Term Contract (Possibility Of Further Extension)
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 userfriendly 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 reorientation and contact user s 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 crossfunctionally with Subject Matter Experts in Calibration/Facilities to ensure minimal impact to Development project teams during installation calibration and validation of
new nonRoche 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 oncall CTU service (when alerted for a temperature excursion) with the other Lab Supervisors. Responsibilities include inhibiting alarms in the CTU monitoring software and coming onsite to relocate contents from the failing CTU to a backup 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.
Education:
Bachelors Degree Biological/Life Sciences Chemistry Biochemistry or related
field or equivalent combination of education and workexperience.
Experience:
34 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
Company Benefits: Medical Dental Vision Paid Sick leave and 401K
Interested! Please apply or send your resume to /