Dosimetry/Microbiology Laboratory Supervisor - Night shift

Dosimetry/ Microbiology Lab Supervisor

Shift: Sun, Mon, Tue every other Sat – 6pm-6am

Responsibilities

• Support electron beam IQ/OQ/PQ validations.
• Perform dosimetry laboratory equipment validations.
• Perform routine dosimetry testing and data analysis.
• Perform dosimeter batch calibrations and dosimeter batch calibration verification audits.
• Troubleshoot dosimetry spectrophotometers and spectrometers and associated computer software.
• Collect, review and analyze dosimetry results to support irradiation process.
• Author, review and execute validation protocols for dosimetry laboratory equipment and test methods.
• Author, review and revise dosimetry work instructions including, but not limited to, operation and calibration.
• Identify and issue Alert/OOL forms for out of limit results.
• Conduct investigations into Alert/OOL excursions.
• Ensure laboratory area is maintained in a GMP state at all times while following all EHS and 5S guidelines.
• Generate, execute and summarize special laboratory studies.
• Ensure personal training requirements are met and that training records are current.
• Cover activities within the organization in support of ISO 9000 requirements.
• Conduct internal audits & process audits.
• Coordinate the corrective action system, driving internal and external issue resolution.
• Coordinate the customer satisfaction program, SCARS analysis and corrective actions.
• Serve as customer liaison for the quality function.
• Prepare analysis of and reports on audit results.

Requirements

• 5 years of lab experience
• 2+ years of dosimetry and/or microbiology experience
• 3+ years of leadership experience
• Previous FDA regulations, medical device industry and ISO13485 experience
• E-beam sterilization experience preferred

Qualifications

• High school diploma or equivalent
• Valid driver's license
• Ability to pass a drug screen and background check

Benefits

• Flexible scheduling
• Health insurance
• Retirement plan
• Employee discounts

Pay

• $X per hour

Schedule

• 6pm-6am