QC Analyst I/II
Alkermes
Full-time
On-site
Wilmington, OH
Operations
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QC Analyst I/II
Overview
The QC Analyst I/II applies comprehensive knowledge of analytical techniques to support routine operations within the chemistry laboratory. Operating in a cGMP-regulated environment, the analyst performs testing, data entry, and periodic data review for raw materials, in-process samples, finished products, stability studies, and clinical trial materials. This role functions as an integral member of the quality team, ensuring timely and compliant execution of laboratory activities aligned with regulatory standards and internal procedures.
Responsibilities
· Perform analytical testing on a variety of sample types including raw materials, in-process samples, finished products, and stability batches using validated methods.
· Execute laboratory test protocols to support method development, validation, and transfer activities in compliance with regulatory standards.
· Operate, maintain, and troubleshoot laboratory instruments (e.g., HPLC, GC, UV-Vis) to ensure accuracy and reliability of results.
· Review QC data for accuracy, completeness, and compliance with specifications and Good Documentation Practices (GDP).
· Support updates to QC methods and SOPs, ensuring clarity, consistency, and alignment with current regulatory expectations.
· Participate in cross-functional collaboration with QA, Manufacturing, and Sampling & Inspection teams to support site-wide compliance and manufacturing goals.
· Maintain a positive team atmosphere through active participation, knowledge sharing, and respectful communication.
· Demonstrate self-motivation and accountability by completing assigned tasks and proactively identifying work priorities.
· Accept and apply feedback during training and routine analysis to ensure consistent performance and growth.
· Safely handle hazardous materials in accordance with safety protocols and regulatory guidelines.
· Adapt quickly to shifting priorities and evolving project needs in a dynamic laboratory setting.
Qualifications
· Bachelor’s degree in Chemistry, Biochemistry, or related scientific discipline required; coursework in analytical techniques and laboratory safety preferred.
· Strong critical thinking and problem-solving skills, with the ability to identify technical issues and implement timely, compliant resolutions.
· Strong critical thinking and problem-solving skills, with the ability to identify technical issues and implement timely, compliant resolutions.
· Excellent organizational and time management skills, with proven ability to plan, schedule, and execute tasks to meet deadlines and quality standards.
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