Quality Assurance Specialist

3 days ago


Wilmington, Ohio, United States Alkermes Full time
About the Role

We are seeking a highly motivated and detail-oriented Quality Assurance Specialist to join our team at Alkermes. As a Quality Assurance Specialist, you will play a critical role in supporting the daily activities related to manufacturing operations and quality systems.

Key Responsibilities
  • Issuance of GxP documentation, ensuring compliance with regulatory requirements.
  • Support the Document Management System, maintaining accurate and up-to-date documentation.
  • Evaluate executed documentation, identifying areas for improvement and implementing corrective actions.
  • Develop and maintain Standard Operating Procedures and quality-related documents.
  • Collaborate with cross-functional teams to support area initiatives and projects.
Requirements
  • Experience in Pharmaceutical Quality Assurance, with a strong understanding of GMP regulations and compliance.
  • Ability to communicate effectively, both written and verbally, with various stakeholders.
  • Strong analytical and problem-solving skills, with attention to detail and a results-oriented approach.
  • Experience in support of quality systems for drug product manufacturing and quality control operations.
  • Working knowledge of US Drug Product GMP requirements and associated guidelines.
What We Offer

As a Quality Assurance Specialist at Alkermes, you will have the opportunity to work in a dynamic and fast-paced environment, collaborating with a talented team of professionals. We offer a competitive salary and benefits package, as well as opportunities for professional growth and development.

Alkermes is an equal employment opportunity employer and does not discriminate against any qualified applicant or employee based on race, creed, color, age, national origin, ancestry, religion, gender, sexual orientation, gender expression and identity, disability, genetic information, veteran status, military status, application for military service, or any other characteristic protected by local, state, or federal law.



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