Require a highly motivated and experienced individual for the position of Sr. QA Associate II. This individual will be part of the External Commercial QA group and will be based in Wilmington, OH. Responsibilities include supporting pharmaceutical Supplier Quality Management activities, performing vendor audits, supporting change control, complaints and queries related to external vendors, troubleshooting issues, develops and implements effective risk mitigation strategies , and 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 functional groups ensuring consistent and best practices are applied throughout the External Commercial QA group.
The qualified candidate will have a proven track record of strong decision making and applying knowledge of policies and standards to complete tasks. Expert knowledge of regulatory requirements and industry expectations for supplier quality is required. 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. 5-7 years’ experience in a Quality Assurance role in the pharmaceutical industry; preferably with parenteral and oral dosage forms. Certification in quality auditing is preferred.
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 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. Identifies opportunities to improve and contributes to problem solving. Willingness to travel 50% of time.
Employer will assist with relocation costs.
Additional Salary Information: Salary plus bonus
Internal Number: 7765
About Alkermes, Inc.
Alkermes is a leader in innovative medicines that address the unmet needs and challenges of people living with debilitating diseases. As a fully integrated global biopharmaceutical company, Alkermes applies our scientific expertise, proprietary technologies and global resources to develop products that are designed to make a meaningful difference in the way patients manage their disease.
Track Record of Innovation
Through our proven scientific, development and manufacturing capabilities, Alkermes is uniquely positioned to be an engine of innovative treatments for major clinical conditions specifically focused on central nervous system (CNS) disorders, such as schizophrenia, depression, addiction and multiple sclerosis.