QC Specialist II/III - Chemistry

Alkermes•Wilmington, OH

4d•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.