add a Dosimetry/ Microbiology Lab Supervisor in Austin, Tx.

Reporting to the Quality Manager, the Dosimetry/ Microbiology Lab Supervisor plans and directs activities concerned with the establishment and/or continuance of ISO 9000 related requirements and other quality programs. Plans and coordinates internal process audits and ensures optimization of the corrective action system within the operation and with external customers and vendors.

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

What a typical day looks like:

• 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.
• Perform review of test data with application of GDP.
• Will be required to perform change requests when required and complete them in a timely manner. Author, review and revise dosimetry work instructions including, but not limited to, operation and calibration.
• Identification and issuance of Alert/OOL forms for out of limit results. May be required to 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.
• May be required to generate, execute and summarize special laboratory studies.
• Ensure personal training requirements are met and that training records are current.
• Coordinates activities within the organization in support of ISO 9000 requirements.
• Conducts internal audits & process audits.
• Coordinates the corrective action system, driving internal and external issue resolution.
• Coordinates the customer satisfaction program, SCARS analysis and corrective actions.
• Serves as customer liaison for the quality function.
• Prepares analysis of and reports on audit results.

The experience we’re looking to add to our team:

• 5 years of dosimetry experience.
• 3+  years of leadership experience
• Previous FDA regulations experience
• Medical device industry and ISO13485 experience prefer
• E-beam sterilization experience prefer

What you'll receive for the great work you provide:

• Full range of medical, dental, and vision plans
• Life Insurance
• Short-term and Long-term Disability
• Matching 401(k) Contributions
• Vacation and Paid Sick Time
• Tuition Reimbursement

Application Deadline:

Applications for this job position will be accepted for at least five days following the job posting start date below and continuing until the end date below or until the position is filled. This posting may close sooner due to application volume.

Is Sponsorship Available?