QC Specialist II/III - Chemistry

Socket.dev; Wilmington (OH); On-site; USD 70,000 - 95,000; Full time

Job summary

Alkermes, Inc. seeks a Quality Control Specialist – Chemistry to support analytical instrumentation in the Quality Control Chemistry Laboratory.

You will ensure instrument specifications meet method requirements, troubleshoot issues, and safeguard data integrity to regulatory standards (FDA, ICH, JP). The role involves overseeing instruments (HPLC, UPLC, GC, LC-MS, UV-Vis, FTIR), authoring URS and risk assessments, maintaining documentation, and delivering instrument training to analysts.

Qualifications

• Bachelors Degree in Chemistry with approx. 2 years of laboratory experience or Masters with approx. 1 year.
• Bachelors Degree in Chemistry with approx. 3-4 years of laboratory experience or Masters with approx. 2 years.

Responsibilities

• Oversee chemistry laboratory instruments, including HPLC, UPLC, GC, LC-MS, UV-Vis, FTIR, dissolution systems.
• Author, update, and maintain user requirement specifications for instruments.
• Create and maintain risk decision records to support instrument purchasing decisions.
• Author, review, and maintain instrument risk assessments for compliance.
• Create and maintain instrument documentation throughout the lifecycle.
• Develop training materials and deliver instrument-specific training to analysts.
• Assist analysts with instrument troubleshooting and submitting work orders.
• Identify opportunities to improve instrument reliability, documentation quality, and training effectiveness.

Skills

Instrument troubleshooting

Technical documentation

Training delivery

QC systems familiarity

Data integrity & compliance

Cross-functional collaboration

Clear communication

Education

Bachelors Degree in Chemistry

Masters Degree in Chemistry

Tools

Empower

LIMS

TrackWise

Job description

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 complianceregulations

PERSONAL ATTRIBUTES:

• Ability to work hard and contribute to an enjoyable rapidly changingworking environment

• Proactively achieves results for the best of theorganization

• Willingness to learn newthings

• Commitment toteamwork

• Commitment to continuous improvement in allareas

• Ability to focus attention to details and ensure high qualitywork

• Ability to work safely; seek out and encourage safepractices

• Takes input from others and stimulates opendiscussions

• Excellent communication and documentationskills

Qualifications

EDUCATION/EXPERIENCE:

QC SPECIALIST II:

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

• Masters Degree in Chemistry with approx. 1 year of laboratoryexperience

QC SPECIALIST III:

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

• Masters Degree in Chemistry with approx. 2 years of laboratoryexperience

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.

#LI-RS1

#LI-Onsite

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.