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Quality System Specialist - Cambridge, United States - eTeam
![eTeam background](https://contents.bebee.com/companies/us/eteam/background-KBOzW.png)
Description
Title: Quality Systems Specialist
Location: Cambridge, MA
Duration: 6 Months
ON-SITE - 9 am - 5 pm / Monday - Friday
Pay Rate: $55.66/hr on W2 All Inclusive
As a Quality Systems Specialist, you will play a crucial role in supporting the Quality Management Systems (QMS) team to ensure compliance with Client policies, QMS standards, and local regulations, reporting directly to the QMS Manager.
This position offers a unique opportunity to collaborate with Manufacturing, Facilities, QA, and QC teams, overseeing QA Compliance activities for the Binney St. site in Cambridge, MA, with a primary focus on managing Quality Systems such as deviations, CAPAs, and change controls. Additional responsibilities may also come up.
- Manage the overall health of Quality Systems by analyzing Key Performance Indicators (KPIs) to drive continuous improvement, spot and address issues promptly.
- Guarantee that quality operations adhere to Client standards, Good Manufacturing Practices (GMP), Good Documentation Practices (GDP), and local regulations.
- Collect and assess metrics related to documentation, deviations, CAPAs, and change controls. Develop and update dashboards and visual aids regularly.
- Organize and lead regular governance meetings involving task owners from different departments to oversee project timelines.
- Spearhead improvement initiatives to streamline processes in accordance with established company standards and regulatory requirements.
- Conduct Quality System process validations to ensure proper management of processes and systems, ensuring the audit readiness of Quality Systems at the site.
- Assist in identifying risks related to Quality Systems and take timely action to mitigate them.
Skill-Set Requirements:
- Exceptional attention to detail
- Strong analytical and organizational capabilities
- Knowledge of Quality Systems, including deviations, CAPAs, and change controls
- Proficiency in:
Excel and Smartsheet for data analysis
Creating clear, concise, and impactful PowerPoint presentations
- Effective facilitation skills to lead governance meetings and collaborate with task owners to track timelines
- Professional conduct when engaging with senior leadership