Quality Assurance Manager

Responsibilities



  • Responsible for company’s Quality Management System, to include ISO 9001 and 17025.
  • Responsible for processing audit CAPAs, including effectiveness checks through closure. Perform all appropriate follow up activities to ensure CAPA closure within a timely manner.
  • Prepare Key Performance Indicator reports and present status in review meetings.
  • Plan and coordinate quality assurance programs and develop quality control policies.
  • Maintain Standard Operating Procedures (SOPs) and ensure their compliance to ISO 9001/17025 requirements and the business’s policies.
  • Audit existing procedures and revise as needed and implement through training.
  • Understand and monitor all operations that affect quality, perform gap analysis, and devise and implement improvement plans.
  • Conducts audits of suppliers as needed.
  • Keep abreast of the ISO changes & enhancements and educate the business on compliance requirements.

Qualifications



  • Working knowledge of ISO 9001 and 17025 Quality Procedures.
  • Recent experience facilitating ISO 9001 and 17025 audits.
  • Excellent communication skills. Demonstrated ability to articulate ideas clearly and concisely in verbal and written form.
  • Experience with current Good Manufacturing Practices (cGMP) a plus.
  • Experience integrating acquired companies into an ISO certified organization.
  • Bachelor’s degree in science (chemistry, analytical chemistry biochemistry, biotechnology or similar) or equivalent lab experience
  • Knowledge of lab practices, standard concepts, and test procedures for analytical instruments
  • In depth knowledge of Quality System Processes
  • MS office skills required.
  • Ability to lift 50 pounds.
  • A valid driver’s license in good standing is mandatory.

Interested parties should send their resume and cover letter to [email protected]