Summary

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

Essential Functions

• Review completed GMP documentation to ensure it is complete and accurate in preparation for product release.
• Work with the Solid Oral Dose 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 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.