Senior Quality Assurance Associate II

Qualifications

• 6+ years of experience in a pharmaceutical quality function
• Thorough knowledge of FDA and EU cGMPs and pharmaceutical manufacturing requirements
• QA Experience in pharmaceutical product development, especially for early phase clinical trials
• Broad quality experience, including manufacturing operations and drug product release
• Strong troubleshooting and problem-solving skills
• Proficiency in risk assessment tools
• Effective planning, organizing, and prioritizing of work

Responsibilities

• Interface with contract manufacturing organizations to ensure compliance with Alkermes Quality policies and cGMPs
• Facilitate review and release processes with the QP
• Maintain and enhance quality systems for regulatory compliance
• Represent the department in cross-site projects
• Monitor quality indicators to identify trends and risks
• Lead or support investigations into quality issues and ensure corrective actions are implemented
• Promote Good Manufacturing Practices (GMPs) in all activities
• Provide quality assurance guidance to development teams for various operations
• Evaluate quality and technical issues related to product development
• Mentor QA Associates and provide performance feedback

Benefits

• Health and wellness programs
• Professional development opportunities
• Flexible work arrangements
• Collaborative work environment
• Performance recognition programs