Pharma QA Associate - Quality Systems & Compliance (Temp)

Socket.dev; Wilmington (OH); On-site; USD 42,000 - 60,000; Full time

Job summary

Alkermes is seeking a temporary professional to support daily manufacturing operations and quality systems in Wilmington, Ohio. The role focuses on ensuring GxP compliance and maintaining documentation integrity across the product lifecycle.

You will issue GxP documents, assist with the Document Management System, develop SOPs, and help evaluate and improve quality records while collaborating with cross-functional teams in a fast-paced biopharma environment.

Qualifications

• Bachelor’s degree in a scientific discipline or equivalent experience.
• 0-2 years’ experience in a Quality Assurance role in the pharmaceutical industry.

Responsibilities

• Issuance of GxP documentation.
• Document Management System Support.
• Support documentation lifecycle (Document Scanning, Verification, Retention, and Destruction).
• Develop Standard Operating Procedures and other quality related documents.
• Evaluation of executed documentation (logbooks, controlled forms, and other documentation).
• Support area initiatives and projects.

Skills

QA Experience

GMP Knowledge

Communication Skills

Quality Systems

GMP Guidance

Education

Bachelor’s degree in Science

Job description

Alkermes is seeking a temporary professional to support daily manufacturing operations and quality systems in Wilmington, Ohio. The role focuses on ensuring GxP compliance and maintaining documentation integrity across the product lifecycle.

You will issue GxP documents, assist with the Document Management System, develop SOPs, and help evaluate and improve quality records while collaborating with cross-functional teams in a fast-paced biopharma environment.