Quality Assurance Associate

ALLTECH CONSULTING SVC INC; Winchester (KY); On-site; USD 55,000 - 75,000; Full time

Job summary

A leading consulting service provider is seeking a QA Associate in Winchester, Kentucky. The candidate must be knowledgeable in GMP regulations and capable of independently evaluating compliance of analytical documentation. Responsibilities include reviewing analytical release and stability data and approving controlled documents with minimal supervision. A BS in science (preferably Chemistry or Biochemistry) and a minimum of 3 years of related industry experience are required.

Qualifications

• Minimum of 3 years of applicable GMP industry experience.
• Experience in analytical laboratory, QC laboratory, Manufacturing, or QA is preferred.

Responsibilities

• Review of analytical release and stability data with minimal supervision.
• Review and approval of controlled documents such as protocols and test methods.

Skills

Critical thinking

Organizational skills

Professional communication

Education

BS science degree, preferably in Chemistry or Biochemistry

Job description

Overview

A QA Associate must be familiar with applicable GMP regulations and systems and have the ability to make independent decisions based those requirements. This individual will be responsible for evaluating the compliance of analytical documentation such as test methods, protocols, and stability and release data with minimal supervision. This individual must demonstrate excellent critical thinking and organizational skills. Professional, effective, and proactive communication with peers, management, and interdepartmental colleagues is required.

Responsibilities

• Essential Duties and Responsibilities include the following. Other duties may be assigned.
• Review of analytical release and stability data, with minimal supervision.
• Review and approval of controlled documents such as protocols, test methods, and specifications.

Education and/or Experience

• Minimum of 3 years of applicable GMP industry experience. Analytical laboratory, QC laboratory, Manufacturing, QA experience may be considered applicable.
• BS science degree, preferably in Chemistry or Biochemistry