QC Specialist II/III - Chemistry

Alkermes; Wilmington (OH); Hybrid; USD 60.000 - 90.000; Vollzeit

Zusammenfassung

Alkermes Quality Control Chemistry Specialist role provides instrumental expertise to ensure data integrity and regulatory compliance. You will oversee HPLC/UPLC/GC/LC-MS/UV-Vis/FTIR systems, author URS, maintain risk records, and drive lifecycle documentation.

You will develop training for analysts, assist with troubleshooting, and contribute to continuous improvement of instrument reliability and documentation across the lab.

Qualifikationen

• Bachelor's degree in Chemistry with 2 years of lab experience or Master's with 1 year.
• Bachelor's degree in Chemistry with 3-4 years for Specialist III.
• Master's degree in Chemistry with 2 years lab experience for Specialist III.

Aufgaben

• Oversee chemistry laboratory instruments (HPLC/UPLC/GC/LC-MS/UV-Vis/FTIR).
• Author and maintain URS for new and existing instruments.
• Create/maintain instrument risk assessments and decision records.
• Maintain instrument documentation and method changes due to CAPAs.
• Develop and deliver instrument-specific analyst training.
• Assist analysts with troubleshooting and work orders.
• Improve instrument reliability and data integrity.
• Collaborate across functions and communicate technical concepts.

Kenntnisse

Instrument operation

Troubleshooting

Data integrity

Documentation

Training delivery

Cross-functional

Risk assessment

Regulatory compliance

Ausbildung

Bachelors in Chemistry

Masters in Chemistry

Tools

HPLC

UPLC

LC-MS

GC

UV-Vis

FTIR

Empower

LIMS

TrackWise

Jobbeschreibung

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.

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About Us

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.