QA ASSOCIATE III/SR. QA ASSOCIATE I/II

Alkermes is seeking a highly motivated and experienced individual for the position of QA Associate III or a Sr. QA Associate I/II, at the Wilmington, OH location. Responsibilities include performing commercial Supplier Quality Management activities for the Wilmington site. This includes execution of vendor audits, Quality agreements, lifecycle management, changes and complaints to external vendors. Troubleshoots issues, develops and implements effective risk mitigation strategies as required. Responsibilities include supporting daily compliance and systems activities.
The candidate will also perform general QA work, using their ability as a skilled contributor in completing tasks where judgment is required in resolving problems and making recommendations. Works on problems of a diverse scope where analysis and problem solving is required. Receives general oversight and guidance on approaches to complete project related tasks. Applies job related skills and understanding of policies and standards in completing tasks.

REQUIRED EDUCATION & EXPERIENCE:

• BS in scientific discipline or equivalent
• QA Associate III: 6-8 years’ experience in the pharmaceutical industry; preferably with parenteral and oral dosage forms.
• Sr. QA Associate I: 8-10 years’ experience in the pharmaceutical industry; preferably with parenteral and oral dosage forms.
• Sr. QA Associate II: 10+ years’ experience in the pharmaceutical industry; preferably with parenteral and oral dosage forms.
• Experience performing supplier audits
• Auditor certification preferred

PREFERRED KNOWLEDGE/SKILLS:

• Working knowledge of US and European Drug Product GMP requirements and associated guidelines, including ISO 9001, ISO13485, and data integrity 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
• Expert knowledge in Quality Systems such as: Documentation, Annual Product Reviews, Change Controls, Investigations, Regulatory Inspections, and Internal/External Audits
• Experience in Pharmaceutical Quality Assurance, including the ability to identify and resolve compliance issues
• Experience in Pharmaceutical Supplier Quality Management, including the ability to lead external audits
• Strong written and oral communication skills
• Strong critical thinking skills
• Active listener, excellent coaching skills, able to carry out crucial conversations

• Supplier Quality Management of commercial materials and service providers
• Lead external audits, write associated audit reports, and follow-up on actions related to audits observations
• Evaluate change control records and manage supplier change notifications
• Coordinate Quality Agreements both new and periodic reviews
• Perform risk assessments and associated risk mitigation plans
• Coordinate supplier nonconformance investigations with vendors
• Notifies management of any atypical trend observed in the quality systems
• Substitutes or represents the QA Manager in meetings and/or projects as needed
• Supports the QA Manager in the coordination of key responsibilities in the area of responsibility
• Develop Standard Operating Procedures and other quality related documents
• Review and approve written procedures and other documents
• Interact with vendors and plant personnel to insure 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