Temp-QA Associate

Alkermes • Wilmington, OH

1d

About The Position

This temporary position supports daily activities related to manufacturing operations and quality systems. The role includes supporting documentation processes and quality initiatives, evaluating executed documentation, and helping maintain compliance with applicable GMP requirements.

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 US 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 US Drug Product GMP requirements and associated guidelines.
• Good computer skills.
• Able to manage multiple duties and tasks and work in a fast-paced environment with multiple issues open simultaneously.
• Detail-oriented, highly organized, efficient, dependable, punctual, and flexible; able to embrace change.
• Team player with a quality commitment, a can-do attitude, and a good work ethic; motivated self-starter and results-oriented.
• Innovative thinker and problem solver who identifies improvement opportunities and contributes to problem solving.
• Ability to use knowledge and interpersonal skills to provide leadership, direction, and development to others.
• Able to motivate personnel and get things done through influence.

Responsibilities

• Issue GxP documentation.
• Provide support for the Document Management System.
• Support the documentation lifecycle, including 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