Job Description

Summary

The Manufacturing Compliance Specialist establishes, monitors, and maintains GMP systems for the Filling manufacturing processes.

Essential Functions

• Review completed GMP documentation to ensure it is complete and accurate in preparation for product release.
• Work with the Filling team to proactively identify and resolve GMP non-compliance issues in the Manufacturing group (Materials, Engineering, Production).
• Write or revise (as required) SOPs and other GMP documentation supporting new or changed manufacturing processes in cooperation with appropriate manufacturing personnel.
• Coordinate (expedite when required) the approval process for GMP documentation between Manufacturing, QA, QC, and Development.
• Assure the resolution of deviation corrective actions, action items from Change Control systems, and any audit non-compliance items.

Required Education and Experience

• Bachelor's degree in a scientific discipline or equivalent experience
• Minimum three years experience in Quality Assurance or manufacturing in the pharmaceutical or medical device industry
• Experience executing and reviewing Good Documentation Practices.

Physical Requirements

Must be able to work in an office and a manufacturing environment.

About Us

Why join Team Alkermes?

Alkermes applies its decades of deep neuroscience expertise to develop medicines designed to help people living with complex and difficult-to-treat psychiatric and neurological disorders. A global biopharmaceutical company, headquartered in Ireland with U.S. locations in Massachusetts and Ohio, we seek to make a meaningful difference in the way people manage their diseases. We have a portfolio of proprietary commercial products for the treatment of alcohol dependence, opioid dependence, schizophrenia, bipolar I disorder and narcolepsy, and a pipeline of clinical and preclinical candidates in development for various psychiatric and neurological disorders.

We are proud to have been recognized as an employer of choice by many national organizations. In 2024 and 2025, we were certified as a Great Place to Work in the U.S. and named one of Massachusetts' Top Places to Work by the Boston Globe, a Best Place to Work in Greater Cincinnati by the Cincinnati Business Courier and recognized as a Best Place to Work in BioPharma by Fortune Magazine.

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.