QC Specialist II/III - Chemistry

The Quality Control Specialist – Chemistry is responsible for providing support for analytical instrumentation support used within the Quality Control Chemistry Laboratory. This role serves as a technical expert, ensuring instrument specifications meet method requirements, providing troubleshooting, and ensuring data integrity meet regulatory expectations (FDA, ICH, JP).

Responsibilities

• Oversee chemistry laboratory instruments, including HPLC, UPLC, GC, LC-MS, UV-Vis, FTIR, dissolution systems, Particle Size Analyzers, and other analytical instrumentation.

• Author, update, and maintain user requirement specifications for new and existing laboratory instruments.

• Create and maintain risk decision records to support instrument purchasing decisions.

• Author, review, and maintain instrument risk assessments to ensure compliance and proper risk control.

• Create and maintain instrument documentation throughout the lifecycle, including updates to methods or instrument procedures driving by changes, CAPAs, or new requirements

• Develop training materials and deliver instrument-specific training to analysts and team members.

• Assist analysts with instrument troubleshooting, escalating issues appropriately, and submitting instrument work orders for the laboratory analysts.

• Identify opportunities to improve instrument reliability, documentation quality, and training effectiveness.

SKILLS/COMPETENCIES:

• Strong understanding of instrument operation, troubleshooting, and lifecycle management

• Experience authoring technical documentation (URS, Risk Assessments, SOPs, etc)

• Ability to deliver clear, structured technical training

• Familiarity with QC systems (Empower, LIMS, TrackWise)

• Strong problem-solving and risk-assessment skills

• Ability to collaborate across functions and communicate technical concepts clearly.

• Strong understanding of data integrity and compliance regulations

PERSONAL ATTRIBUTES:

• Ability to work hard and contribute to an enjoyable rapidly changing working environment

• Proactively achieves results for the best of the organization

• Willingness to learn new things

• Commitment to teamwork

• Commitment to continuous improvement in all areas

• Ability to focus attention to details and ensure high quality work

• Ability to work safely; seek out and encourage safe practices

• Takes input from others and stimulates open discussions

• Excellent communication and documentation skills

Qualifications

EDUCATION/EXPERIENCE:

QC SPECIALIST II:

• Bachelors Degree in Chemistry with approx. 2 years of laboratory experience or

• Masters Degree in Chemistry with approx. 1 year of laboratory experience

QC SPECIALIST III:

• Bachelors Degree in Chemistry with approx. 3-4 years of laboratory experience or

• Masters Degree in Chemistry with approx. 2 years of laboratory experience

Company Overview

Alkermes, Inc. is an equal employment opportunity employer and does not discriminate against any applicant 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 class protected by state or federal law.

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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.