QC Specialist II/III - Chemistry

Alkermes • Wilmington, OH

3d • Onsite

About The Position

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).

Requirements

• 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
• Bachelors Degree in Chemistry with approx. 2 years of laboratory experience or Masters Degree in Chemistry with approx. 1 year of laboratory experience (for QC Specialist II)
• Bachelors Degree in Chemistry with approx. 3-4 years of laboratory experience or Masters Degree in Chemistry with approx. 2 years of laboratory experience (for QC Specialist III)

Nice To Haves

• 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

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.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level