Regulatory Compliance Associate

6 days ago


Wilmington, Ohio, United States Alkermes Full time
About the Role

We are seeking a highly skilled Quality Control Specialist to join our team at Alkermes. As a key member of our Quality Assurance department, you will play a critical role in ensuring the quality and integrity of our products.

Key Responsibilities
  • Sampling and Inspection: Conduct thorough sampling and inspection of incoming materials, including raw materials, active pharmaceutical ingredients, excipients, and components.
  • Documentation and Record-Keeping: Review and maintain accurate documentation, including Certificates of Analysis (CoAs), and assign expiration and retest dates for incoming raw materials.
  • Collaboration and Communication: Work closely with cross-functional teams, including Quality Assurance, Manufacturing, Receiving, and Supply Chain, to ensure seamless execution of quality control processes.
  • Problem-Solving and Troubleshooting: Identify and report any discrepancies or defects, and collaborate with teams to resolve issues and implement corrective actions.
  • Technical Expertise: Develop and maintain expertise in sampling techniques, laboratory procedures, and regulatory requirements.
  • Training and Development: Provide training and guidance to colleagues on quality control procedures and regulatory requirements.
Requirements
  • Education and Experience: Associate's degree or equivalent experience required; Bachelor's degree in a scientific discipline preferred. A minimum of 1 year experience in a pharmaceutical or regulated industry preferred.
  • Skills and Qualifications: Ability to comprehend and follow standard operating procedures, strong understanding of cGMP concepts. Ability to handle multiple projects with competing priorities. Fundamental understanding of mathematics. Intermediate skills in computer use with ability to learn and master new computer applications.
About Alkermes

Alkermes is a global biopharmaceutical company dedicated to developing innovative medicines for complex and difficult-to-treat psychiatric and neurological disorders. We are committed to pursuing great science, driven by deep compassion to make a real impact in the lives of patients. Our company culture values diversity, inclusion, and belonging, and we strive to foster a workplace where all voices are respected and valued.



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