QC Analyst I/II

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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Why join Team Alkermes?

Alkermes applies its deep neuroscience expertise to develop medicines designed to help people living with complex and difficult-to-treat psychiatric and neurological disorders. A fully-integrated, global biopharmaceutical company, headquartered in Ireland with U.S. locations in Massachusetts and Ohio, we are committed to pursuing great science, driven by deep compassion to make a real impact in the lives of patients. Alkermes has a portfolio of proprietary commercial products for the treatment of alcohol dependence, opioid dependence, schizophrenia and bipolar I disorder, and a pipeline of clinical and preclinical candidates in development for various neurological disorders, including narcolepsy.

Beyond our important mission of developing medicines to address unmet patient needs, we actively seek to foster a culture of diversity, inclusion and belonging throughout our business. We strive to ensure that all voices are respected and valued, recognizing that our diversity of thought, background and perspective makes us stronger. We are proud to have been recognized as an employer of choice by many national organizations, including being certified as a Great Place to Work in the U.S. in 2024, honored as a Healthiest Employer in both Ohio and Massachusetts in 2023, a Best Place for Working Parents in 2023, and to have received the Bell Seal at the Platinum level for Workplace Mental Health by Mental Health America for three consecutive years (2021-2023). 

Alkermes, Inc. is an equal employment opportunity employer and does not discriminate against any qualified applicant or employee because of race, creed, color, age, national origin, ancestry, religion, gender, sexual orientation, gender expression and identity, disability, genetic information, veteran status, military status, application for military service or any other characteristic protected by local, state or federal law.  Alkermes also complies with all work authorization and employment eligibility verification requirements of the Immigration and Nationality Act and IRCA.  Alkermes is an E-Verify employer.