Design Control Expert

2 weeks ago


Wilmington, Ohio, United States Alkermes Full time

Alkermes is seeking a highly motivated and experienced Quality Assurance professional to join our team as a QA Associate II. This is an excellent opportunity to develop your career in a dynamic and growing organization.

The successful candidate will have a strong background in quality assurance, with a solid understanding of US Drug Product GMP requirements and associated guidelines. They will also have experience in pharmaceutical quality assurance, including the ability to identify and resolve compliance issues.

Key Responsibilities

  • Support design control activities, including device assessments, document review, training program support, TrackWise reporting, shift communication, and CAPA tracking
  • Develop and implement Standard Operating Procedures and other quality-related documents
  • Collaborate with plant personnel to ensure CGMP compliance
  • Prepare and maintain batch data tables for trend analysis

Qualifications

  • Working knowledge of US Drug Product GMP requirements and associated guidelines
  • 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, specifically design controls
  • Strong written and oral communication skills
  • Experience in administration of quality systems for drug product manufacturing and quality control operations

Salary Information

The estimated salary for this position is $70,000 - $90,000 per year, depending on location and experience.



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