Contract QA Associate – Pharma Quality & Documentation

Alkermes; Cincinnati (OH); On-site; USD 34,000 - 55,000; Full time

Job summary

Alkermes is seeking a temporary Quality Assurance support role in Cincinnati, OH to assist manufacturing operations and quality systems. Responsibilities include issuing GxP docs, maintaining the Document Management System, and developing SOPs while ensuring compliance with GMP guidelines.

The candidate should have 0–2 years of QA experience in the pharmaceutical industry, strong communication skills, and the ability to work in a fast-paced environment with a team.

Qualifications

• Bachelor’s degree in a scientific discipline or equivalent experience.
• 0–2 years’ QA experience in pharmaceutical industry.
• Knowledge of US and European GMP regulations and guidance.

Responsibilities

• Issue GxP documentation.
• Support Document Management System.
• Manage document lifecycle (scanning, verification, retention, destruction).
• Develop SOPs and other quality documents.
• Evaluate executed documentation (logbooks, forms).
• Support area initiatives and projects.

Skills

Quality Assurance experience

GMP knowledge

Written and verbal communication

Quality systems support

Documentation management

Education

Bachelor’s degree in a scientific discipline

Job description

Alkermes is seeking a temporary Quality Assurance support role in Cincinnati, OH to assist manufacturing operations and quality systems. Responsibilities include issuing GxP docs, maintaining the Document Management System, and developing SOPs while ensuring compliance with GMP guidelines.

The candidate should have 0–2 years of QA experience in the pharmaceutical industry, strong communication skills, and the ability to work in a fast-paced environment with a team.