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).
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Oversee chemistry laboratory instruments, including HPLC, UPLC, GC, LC-MS, UV-Vis, FTIR, dissolution systems, Particle Size Analyzers, and other analytical instrumentation.
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Author, update, and maintain user requirement specifications for new and existing laboratory instruments.
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Create and maintain risk decision records to support instrument purchasing decisions.
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Author, review, and maintain instrument risk assessments to ensure compliance and proper risk control.
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Create and maintain instrument documentation throughout the lifecycle, including updates to methods or instrument procedures driving by changes, CAPAs, or new requirements
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Develop training materials and deliver instrument-specific training to analysts and team members.
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Assist analysts with instrument troubleshooting, escalating issues appropriately, and submitting instrument work orders for the laboratory analysts.
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Identify opportunities to improve instrument reliability, documentation quality, and training effectiveness.
SKILLS/COMPETENCIES:
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Strong understanding of instrument operation, troubleshooting, and lifecycle management
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Experience authoring technical documentation (URS, Risk Assessments, SOPs, etc)
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Ability to deliver clear, structured technical training
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Familiarity with QC systems (Empower, LIMS, TrackWise)
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Strong problem-solving and risk-assessment skills
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Ability to collaborate across functions and communicate technical concepts clearly.
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Strong understanding of data integrity and compliance regulations
PERSONAL ATTRIBUTES:
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Ability to work hard and contribute to an enjoyable rapidly changing working environment
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Proactively achieves results for the best of the organization
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Willingness to learn new things
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Commitment to teamwork
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Commitment to continuous improvement in all areas
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Ability to focus attention to details and ensure high quality work
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Ability to work safely; seek out and encourage safe practices
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Takes input from others and stimulates open discussions
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Excellent communication and documentation skills
EDUCATION/EXPERIENCE:
QC SPECIALIST II:
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Bachelors Degree in Chemistry with approx. 2 years of laboratory experience or
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Masters Degree in Chemistry with approx. 1 year of laboratory experience
QC SPECIALIST III:
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Bachelors Degree in Chemistry with approx. 3-4 years of laboratory experience or
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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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