Position Summary:

Alkermes is seeking a highly motivated and experienced individual for the position of Sr. QA Associate I, at the Wilmington, OH location.  Responsibilities include supporting daily compliance and systems activities.  Performs customer complaints investigations approval, writes Annual Product Reviews (APR’s), and performs internal audits as assigned. Also documents complaints investigations in the electronic database system ensuring compliance with the Good Manufacturing Practices (GMPs), and regulations.

The candidate will 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.

Responsibilities:

• Evaluation and approval of customer complaints investigations.
• Writes Annual Product Reviews (APR’s).
• Performs Internal Audits as assigned.
• Supports regulatory audits
• 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.
• Assists and analyzes information regarding complaints received and assures investigations are in accordance with current procedures, GMPs, and policies.
• Collaborates in the development of action plans addressed to prevent and eliminate root cause to reduce product complaints.
• Creates complaints reports as required.
• Notifies the QA Manager of atypical trends observed in the customer complaints system.
• Analyzes trends related to customer complaints to identify action plans to prevent recurrence.
•  Participates 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 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.
• Combination Product/Design Control Experience desired.

Qualifications:

• Minimum Education & Experience Requirements:
  • BS in 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.
• Knowledge/Skills Needed:
  • 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
  • Strong written and oral communication skills
• Personal Attributes Needed:
  • Team Player committed to quality; motivated self-starter; detail and results oriented; Well organized, efficient worker with good communication skills; innovative thinker and problem solver; flexible and can embrace change; can manage multiple duties and tasks
  • Can get things done on the basis of influence
  • Can work in a fast-paced environment with multiple issues open simultaneously
  • Attention to detail
  • Identifies opportunities to improve and contributes to problem solving

#LI-RS1

#Onsite