Description

ADMA Biologics is a biopharmaceutical company relentlessly committed to creating superior products for immunodeficient patients at risk for infection. It is our devotion to this underserved population that fuels us and our hands-on approach to production and development that sets us apart.  If you are looking for a dynamic, innovative, growing company in the biopharmaceutical industry that is committed to excellence and integrity, then consider ADMA Biologics.  We currently have an exciting opportunity available for a Group Leader, Microbiology for Environmental Monitoring in Boca Raton, FL!

 

The Group Leader, Microbiology for Environmental Monitoring will supervise and be responsible for daily operation of the environmental monitoring (EM) program. Ensure all environmental monitoring is performed in accordance to cGMP, regulatory guidelines, and company standard operating procedures.  This position is responsible for overseeing 5-7 analysts and their routine tasks. The position is viewed as a proficient, skilled, subject matter expert in Quality Control, method development/validation, and quality system compliance and will use knowledge and creativity to resolve complex problems.

Qualifications

• Act as an SME during investigations, audits, and regulatory inspections. 
• Ensure compliance to regulatory guidance.
• Identify and execute process improvement opportunities.
• Participate in laboratory, environmental excursion, and deviation investigations.
• Perform quality control testing for raw materials, product, and environmental monitoring samples. 
• Complete testing documentation, and data entry as required for procedures and tests performed.
• Perform review and verification of data in a timely manner and in accordance with SOPs.
• Provide appropriate guidance to troubleshoot and resolve problems.
• Provide leadership and mentor a team of EM analysts by scheduling routine tasks, specials projects, and trainings. 
• Set goals to develop team expertise and monitor team performance.
• Select, develop, and troubleshoot test methods for quality control testing of environmental monitoring, product, and raw material samples.
• Track, trend, and analyze environmental monitoring data to prepare written reports and data summaries.
• Write and revise Standard Operating Procedures and methods.
• Write, and oversee the execution of validation protocols, or other special projects for microbiological testing to support manufacturing activities.
• Approve employees’ timecards as related to PTO, jury duty, etc.

 

Education Requirements:    
B.S. or M.S. in biochemistry, biological sciences, microbiology, biotechnology molecular and cellular biology, or related science discipline. 

 

Experience Requirements:    
At least eight years of experience in a Microbiological/Biochemical/Chemical laboratory, including experience in a federally regulated environment (FDA, EPA, etc.).  Knowledge of FDA regulations for cGMP requirements is an essential pre-requisite for this position.  Supervisory experience is preferred. 
 

In addition to competitive compensation, we offer a comprehensive benefits package including:

• 401K plan with employer match and immediate vesting
• Medical, Vision, Life and Dental Insurance
• Pet Insurance 
• Company paid STD and LTD
• Company Paid Holidays 
• 3 Weeks’ Paid Time Off (within the first year)
• Tuition Assistance (after the first year)
• Easily accessible to Tri-Rail
• Free Shuttle to the Boca Tri-Rail station

 

ADMA Biologics uses E-Verify to confirm the employment eligibility of all newly hired employees. To learn more about E-Verify, including your rights and responsibilities, please visit www.dhs.gov/E-Verify. 

 

ADMA Biologics is an Equal Opportunity Employer.

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