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).

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, Track Wise)

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 newthings

Commitment to teamwork

Commitment to continuous improvement in allareas

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

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 laboratory experience

QC SPECIALIST III:

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

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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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…