Laboratory Manager

TONAWANDA, NY

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Description

 Laboratory Manager / Tonawanda, NY

 

Remedy is partnered with a growing,  international production facility in Tonawanda to identify a Laboratory Manager to have supervisory responsibility for Quality staff, while leading responsibility for several areas of the Quality Management system.

 

 

Responsibilities:

  • Effectively leading and ensuring the development and success of the laboratory technicians
  • Making appropriate regulatory and risk-based decisions regarding Microbiology and analytical testing results
  • Driving laboratory function to ensure maintenance of regulatory compliance regarding product testing, real-time stability, test method development, raw material specification development, drug and cosmetic product specification, lab equipment preventive maintenance, certificates of analysis, external 3rd party microbiological testing.
  • Responsible for validation program for lab equipment, cleaning, and water system validations. 
  • Managing real time stability program in compliance with our standard and FDA regulations.
  • Driving completion and effectiveness of Corrective and Preventive actions, Planned Deviations, Deviations, support customer complaint resolutions
  • Assisting the Director and the Quality Supervisor with the management of the contract laboratories and contract manufactures.
  • Performing data/trend analysis and use it to effectively drive continuous improvement
  • Driving  process utilizing laboratory technicians for Annual Product Review (APR) execution
  • Supporting the Quality Assurance and Research and Development teams in the various duties and be the back-up to your lab technicians or ensure other technicians are cross trained.
  • Performing additional job-related duties as needed.

 

Requirements

  • Microbiology and Analytical methodology
  • Experience maintaining regulatory compliance in FDA related field
  • Strong micro and analytical experience and knowledge. 
  • Highly organized with strong attention to detail
  • Process oriented mindset with strong drive for continuous improvement
  • Strong communication skills, both verbal and written
  • Strong data analysis skill with ability to interpret trends and drive improvements based on data.
  • Proficient in Microsoft Office
  • Bachelor’s degree in quality or related field preferred
  • Manager or Supervisory experience  preferred
  • Previous experience in a manufacturing environment, preferably in a drug, or cosmetic company
  • Validation Experience
  • Proficiency in QAD

 

Great opportunity with an established and growing Tonawanda Manufacturer! Apply today!

 

Military Veterans encouraged to apply!

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