Microbiology Supervisor - Lab

4 days left

McCall and Lee
Charlotte, North Carolina, US
May 20, 2021
Jun 23, 2021
Employment Type
Full time
Salary Type
Microbiology Supervisor - Lab

McCall and Lee have been asked to search for a Microbiology Supervisor for a hospital in North Carolina.

You will Supervise Laboratory Technicians and Analysts to ensure Quality / Compliance, product testing, cleanroom environmental monitoring objectives, validation, and product release goals are met. The lab supervisor will assist with maintaining quality engineering programs, standards and improvements within the organization.

We are looking for someone who demonstrates:
• Intense collaboration
• Passionate customer focus
• Thoughtful, fast, disciplined execution
• Tenacious commitment to continuous improvement
• Organized, honest and strong work ethic

Here is some of what you'll need (required):
• Bachelor's Degree in Microbiology or equivalent field of study
• Experience with FDA regulations and other medical device and international standards
• 5+ years laboratory experience
• 2+ years laboratory supervisory experience
• Test method validation and equipment qualification experience required

Here are a few of our preferred experiences:
• Proficient in Microsoft Office
• Excellent technical writing skills
• Strong conflict resolution skills
Here are a few examples of what you'll get for the great work you provide:
• Full range of medical benefits, dental, vision
• Life Insurance
• Matching 401K
• Tuition Reimbursement
• Employee discounts at local retailers

Job Requirements:
• Review, analyze, and disposition and develop when needed Endotoxin/LAL data/test method, to support sterilizing processes.
• Ensures that all testing including endotoxin, environmental assays, product bioburden are reviewed and verified to support sterile product release.
• Assist with investigation and recommendation of corrective actions in the event of out-of-specification and out-of- trend results.
• Author, review and execute validation protocols (IQ/OQ/PQ) for various lab equipment, product, process, system, test method, sterilization, cleaning and equipment qualifications and instrumentation in accordance with site procedures and industry guidance's (USP, ICH, ISO and FDA).
• Ensure Environmental Monitoring is performed to schedule for ISO 8 and 9 cleanrooms and areas.
• Assist with Development and initiation of standards and methods for inspection, testing and evaluation.
• Devises sampling procedures and designs and develops forms and instructions for recording, evaluating and reporting quality and reliability data.
• Directs workers engaged in measuring and testing product and tabulating data concerning materials, product or process quality and reliability.
• Assists with Compiling and writing training material and conducting training sessions on quality control activities.
• Supports Product Engineers and Quality Program Managers with customer interfaces as necessary on quality related issues.
• Initiates corrective action requests as needed and tracks to satisfactory completion.
• Assists with development and implementation of quality audits.
• Approves product, process and equipment qualifications.
• Provides liaison to various regulatory bodies

For consideration contact the recruiter below:

Direct: 404 905 9777

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