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.
- 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.
- 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!