Temp-QA Associate

Alkermes • Wilmington, OH

2d

About The Position

This temporary role supports daily activities related to manufacturing operations and quality systems. The associate supports GxP documentation issuance and management, documentation lifecycle processes, development and review of quality documentation, and area initiatives and projects.

The role requires pharmaceutical quality assurance experience, familiarity with GMP requirements and quality systems supporting drug product manufacturing and quality control operations, and the ability to identify and resolve compliance issues. The associate is expected to communicate effectively, work collaboratively in a fast-paced environment, manage multiple tasks, and contribute to quality improvements and problem solving.

A bachelor’s degree in a scientific discipline or equivalent experience is required. The stated experience range is 0–2 years in a pharmaceutical-industry Quality Assurance role.

Requirements

• Bachelor’s degree in a scientific discipline or equivalent experience.
• 0–2 years of experience in a Quality Assurance role in the pharmaceutical industry.
• Experience in Pharmaceutical Quality Assurance, including the ability to identify and resolve compliance issues.
• Ability to increase others’ knowledge of U.S. and European GMP regulations and guidance.
• Strong written and oral communication skills.
• Experience supporting quality systems for drug product manufacturing and quality control operations.
• Working knowledge of U.S. Drug Product GMP requirements and associated guidelines.
• Good computer skills.
• Ability to manage multiple duties and tasks and work in a fast-paced environment with multiple issues open simultaneously.
• Strong organization and attention to detail.
• Dependability, punctuality, flexibility, and a good work ethic.
• Ability to use knowledge and interpersonal skills to provide leadership, direction, and development of others.
• Ability to influence, motivate personnel, identify improvement opportunities, and contribute to problem solving.
• Team-oriented, self-motivated, results-oriented, innovative, and adaptable approach.

Responsibilities

• Issue GxP documentation.
• Support the Document Management System.
• Support the documentation lifecycle, including document scanning, verification, retention, and destruction.
• Develop Standard Operating Procedures and other quality-related documents.
• Evaluate executed documentation, including logbooks, controlled forms, and other documentation.
• Support area initiatives and projects.

What This Job Offers

• Career Level: Entry Level