Job Title: Field QA Specialist
Location: Devens, MA (Onsite)
Job Summary:
- Join our client’s team as a Field Quality Assurance Specialist at their Single Use Facility in Devens, MA. This role is 100% onsite, with a work schedule from Monday to Friday, 07:00 AM – 03:30 PM EST. The successful candidate will be responsible for ensuring manufacturing compliance with applicable procedures and batch records, providing real-time review of manufacturing documentation, and working with operations to resolve manufacturing issues.
Job Responsibilities:
- Conduct on-the-floor QA activities.
- Ensure manufacturing compliance with applicable procedures and batch records.
- Perform real-time review of manufacturing batch records.
- Review manufacturing shop floor documentation.
Education Requirements:
- High School Degree required.
- Relevant college or university degree preferred.
- Minimum 4 years relevant work experience, with experience in a Quality Assurance role.
Skills Required:
- Ability to work independently and make decisions for non-routine issues.
- Strong knowledge and experience in FDA regulated cGMP warehousing, Quality, and compliance environments.
- Ability to build relationships internally and with cross-functional teams.
- Strong authorship and ability to critically review investigations, interpret results, and generate technical conclusions consistent with Quality Risk Management principles.
- Knowledge of quality processes, including material disposition, change control, product complaints, deviations, investigations, and CAPA management.
- Ability to effectively multi-task.
About SSi People:
With over 26 years of industry experience, SSi People has built its reputation and expertise on putting people first. Everything we do works toward delivering an exceptional experience for our consultants, our clients, and our internal team. Through a genuine commitment to people in everything we do. We have developed refined processes and a stellar internal team to deliver talent quickly. More importantly, we focus on building long-term relationships, not transactions. Putting people first is just what we do well.
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