QC Documentation & Data Review Specialist III

Artech Information System LLC; Framingham (MA); On-site; USD 70,000 - 90,000; Full time

Job summary

A leading IT company in Massachusetts is looking for a QC Documentation Specialist III. This role involves reviewing assay data, archiving QC documents, and training staff on document systems. The ideal candidate should have a degree in Life Sciences, 5+ years of relevant experience, and strong skills in HPLC and Empower software. Excellent communication skills are essential as the role requires collaboration and handling multiple document requests in a fast-paced environment.

Qualifications

• 5+ years of experience in a QC role or a master's degree and 3+ years.
• Experience with QA/QC data review in a regulated industry is essential.
• Knowledge of GDP and cGMP is necessary.

Responsibilities

• Review assay data for completeness according to SOPs, GDP, and regulatory standards.
• Archive and retrieve QC documents, maintain systems for document storage.
• Train employees on efficient system usage and interact with coworkers.

Skills

Detail-oriented

Strong interpersonal skills

Excellent oral communication

Excellent written communication

Highly organized

Experience with HPLC

Knowledge of FDA regulations

Education

Degree in Life Sciences discipline

Tools

Empower software

Job description

A leading IT company in Massachusetts is looking for a QC Documentation Specialist III. This role involves reviewing assay data, archiving QC documents, and training staff on document systems. The ideal candidate should have a degree in Life Sciences, 5+ years of relevant experience, and strong skills in HPLC and Empower software. Excellent communication skills are essential as the role requires collaboration and handling multiple document requests in a fast-paced environment.