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Senior Quality Assurance Associate

1 month ago

Wilmington, Delaware, United States Alkermes Full time
Job Summary:

Alkermes is seeking a highly skilled and experienced Quality Assurance Associate to support daily compliance and systems activities. The ideal candidate will have a strong background in quality assurance, with experience in customer complaints investigations, approval, and writing Annual Product Reviews (APRs).

Key Responsibilities:

• Evaluate and approve customer complaints investigations
• Write Annual Product Reviews (APRs)
• Perform internal audits as assigned
• Support regulatory audits
• Notify management of any atypical trends observed in the quality systems
• Substitute or represent the QA Manager in meetings and/or projects as needed
• Assist and analyze information regarding complaints received and assure investigations are in accordance with current procedures, GMPs, and policies
• Collaborate in the development of action plans addressed to prevent and eliminate root cause to reduce product complaints
• Create complaints reports as required
• Notify the QA Manager of atypical trends observed in the customer complaints system
• Analyze trends related to customer complaints to identify action plans to prevent recurrence
• Participate in the preparation, revision, and update of documents related to the complaints escalation to management as needed
• Monitor the complaints investigations cycle time, assuring complaints are closed within their due date
• Develop Standard Operating Procedures and other quality-related documents
• Authority to approve written procedures and other documents
• Knowledge in Quality Systems such as: Documentation, Annual Product Reviews, Change Controls, Investigations, Regulatory Inspections, and Internal/External Audits
• Follow-up on actions related to audits' observations
• Interact with plant personnel to ensure CGMP compliance
• Provide support to projects, metrics, and other quality systems, when needed
• Serves as a Subject Matter Expert, and support activities in the area
• Combination Product/Design Control Experience desired

Requirements:

• Bachelor's degree in a scientific discipline or equivalent
• 8-10 years' experience in a Quality Assurance role in the pharmaceutical industry; preferably with parenteral and oral dosage forms
• Broad experience handling customer complaints investigations and approval
• Working knowledge of US and European Drug Product GMP requirements and associated guidelines with ability to increase others' knowledge
• Experience in administration of quality systems for drug product development, manufacturing, and quality assurance operations and working in the quality systems, regulatory, and quality compliance areas in an industry regulated by FDA, pharmaceutical, or medical device industries
• Experience in Pharmaceutical Quality Assurance, including the ability to identify and resolve compliance issues