Require a highly motivated and experienced individual for the position of Sr. QA Associate III. This individual will be part of the External Commercial QA group and will be based in Wilmington, OH. Responsibilities include supporting Supplier Quality Management activities. Performs vendor audits, supports changes, complaints and queries related to external vendors. Troubleshoots issues, develops and implements effective risk mitigation strategies as required. Collaborates with site operations to insure site expectations of vendors are adhered to and issues are resolved in a timely manner. Works effectively with global SQM function ensuring consistent and best practices are applied throughout the External Commercial QA group.
Strong decision maker, applying job related skills and understanding of policies and standards in completing tasks. Expert knowledge on regulatory requirements and industry expectations for Supplier Quality. Works on tasks of a diverse scope where analysis and judgment is required in resolving problems and making recommendations. Strong focus on continuous improvement, customer service and collaboration. Ability to perform with minimal supervision.
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. Certified Quality Auditor is consider a plus
Working knowledge of US and European Drug Product GMP requirements and associated guidelines with ability to increase others knowledge. Experience in administration and development of of quality systems. Experience in Pharmaceutical Quality Assurance, including the ability to identify and resolve compliance issues. Strong written and oral communication skills. Ability to be influential across levels of the organization
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. Customer service mindset. Identifies opportunities to improve and contributes to problem solving.
Alkermes, Inc. is an equal employment opportunity employer and does not discriminate against any applicant because of race, creed, color, age, national origin, ancestry, religion, gender, sexual orientation, disability, genetic information, veteran status, military status, application for military service or any other class protected by state or federal law.