Quality Assurance Specialist

LanceSoft Inc; Milford (MA); On-site; USD 70,000 - 90,000; Full time

Job summary

A leading biotechnology company is seeking a Quality Assurance Professional to join its Internal QA team. This role involves supporting commercial QA compliance, assisting with deviation and CAPA reviews, and contributing to data analysis for metrics. Candidates should demonstrate proficiency in Microsoft applications and possess strong communication skills.

Qualifications

• Proficiency with Microsoft applications is essential.
• Experience with Track-Wise is preferred.
• Strong written and oral communication skills are required.

Responsibilities

• Support Commercial QA Compliance including Deviation Review.
• Assist with CAPA Review and Trending.
• Contribute to data analysis and metrics for QMR and KPIs.

Skills

Microsoft Outlook

Microsoft Word

Microsoft Excel

Microsoft Project

Microsoft PowerPoint

Track-Wise

Strong communication skills

Job description

Overview

The Quality Assurance Professional will work in the Internal QA team of Client’s Human Genetic Therapies Quality Assurance Department. This unit oversees internal manufacturing on behalf of Shire.

Responsibilities include support of Commercial QA Compliance: Deviation Review and Trending, CAPA Review and Trending, Extension request review and trending; support of data analysis and metrics for QMR, KPIs, and other reportable forums.

Qualifications / Skills

Proficiency with Microsoft applications Outlook, Word, Excel, Project, and PowerPoint; experience with Track-Wise, ability to learn additional software applications as the need arises. Strong written and oral communication skills required.

Additional Information

All your information will be kept confidential according to EEO guidelines.