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Quality Assurance Specialist

2 months ago

Westbrook, Maine, United States KYYBA Full time
Job Overview

The role of **Quality Assurance Specialist** is integral to our operations within the Infectious Disease Developed Markets division. This position is essential for upholding the quality standards of our products, ensuring compliance with the regulations set forth by various governing bodies.

Key Responsibilities:

  • Conduct testing on in-process components for various product lines including Lateral Flow, ELISA, and Molecular diagnostics.
  • Execute final release testing for Lateral Flow, ELISA, and Molecular products.
  • Identify and troubleshoot technical and quality-related issues.
  • Implement new procedures while adhering to established safety protocols.
  • Perform technical procedures and operate laboratory equipment efficiently.
  • Review and verify batch records for accuracy.
  • Calibrate and maintain laboratory instruments to ensure optimal performance.
  • Adhere to Good Manufacturing Practices (GMP) and Good Laboratory Practices (GLP).

Educational Requirements:

  • An Associate's degree in Biology, Chemistry, Life Sciences, or a related technical field, or an equivalent combination of education and experience.
  • A minimum of 1 year of experience in a laboratory or quality control setting is preferred.

Qualifications:

  • At least 2 years of experience in a regulated industry.
  • Familiarity with GMP, FDA, ISO, and USDA regulations is essential.
  • Experience with pipetting techniques is advantageous.

Competencies:

  • Proficient in using internet software, MRP Inventory/Manufacturing software, and Microsoft Office Suite (Outlook, Excel, and Word).
  • Knowledgeable in enzyme and/or immunochromatographic assays, inspection and measurement systems, systematic troubleshooting, as well as statistics and data analysis.