QC Specialist II/III - Chemistry

Alkermes; Wilmington (OH); On-site; USD 65,000 - 90,000; Full time

Job summary

Alkermes in Wilmington, OH, is seeking a Quality Control Specialist - Chemistry to support analytical instrumentation in the QC Chemistry Laboratory. You will ensure instrument specs meet method requirements, troubleshoot, and safeguard data integrity to regulatory standards (FDA, ICH, JP).

You will oversee instruments such as HPLC, UPLC, GC, LC-MS, UV-Vis, FTIR, dissolution, particle size analyzers, and related systems; author URS, risk assessments, SOPs; develop training; improve reliability

Qualifications

• Bachelor's Degree in Chemistry with approx. 2 years of laboratory experience for level II; Masters with 1 year for level II.
• Bachelor's Degree in Chemistry with approx. 3-4 years of laboratory experience or Masters with approx. 2 years for level III.

Responsibilities

• Oversee chemistry laboratory instruments including HPLC, UPLC, GC, LC-MS, UV-Vis, FTIR, dissolution systems, and particle size analyzers.
• 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, and submitting instrument work orders.
• Identify opportunities to improve instrument reliability, documentation quality, and training effectiveness.

Skills

Instrument operation

Troubleshooting

Documentation

Data integrity

Cross-functional collaboration

Technical training

QC systems familiarity

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).

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

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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