Microbiology Lab Supervisor

Employer
Flex
Location
Balcones, Texas, US
Salary
Competitive
Posted
May 02, 2021
Closes
May 05, 2021
Ref
2136155204
Discipline
Biology
Employment Type
Full time
Salary Type
Salary
Flex is the manufacturing partner of choice that helps a diverse customer base design and build products that improve the world. Through the collective strength of a global workforce across 30 countries and responsible, sustainable operations, Flex delivers technology innovation, supply chain, and manufacturing solutions to various industries and end markets.

The Microbiology Lab Superviso r will be based in Austin, TX . Supervise Laboratory Technicians and Analysts to ensure Quality / Compliance, product testing, cleanroom environmental monitoring objectives, validation, and product release goals are met. 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
  • PTO
  • Tuition Reimbursement
  • Employee discounts at local retailers


Job Requirements:

Here is a glimpse of what you'll do:
  • 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.

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