Job Title: Senior Quality Assurance Associate
Location: West Greenwich, Rhode Island (On-Site)
Job Summary: We are seeking a detail-oriented quality professional to support manufacturing activities with real-time oversight and strong GMP documentation review. Our team is looking for someone who can collaborate effectively, navigate ambiguity, and help ensure quality, compliance, and operational readiness across the floor.
Responsibilities:
- Provide quality oversight for bulk drug substance manufacturing activities and support real-time decision-making related to quality requirements and deviations.
- Review and approve cGMP processes, procedures, documents, and records, including logbooks, batch records, attachments, work orders, and other GMP documentation.
- Ensure production records and testing results are complete, accurate, and documented in accordance with written procedures and cGMP requirements.
- Communicate and collaborate with the shift team to complete required tasks and alert management to quality, compliance, supply, and safety risks.
Required:
- cGMP experience is required.
- Ability to work 100% on-site and spend the majority of the shift in clean room space, including gowning in and out of frocks and coveralls.
- Strong knowledge of good documentation practices and data integrity requirements.
- Proficiency in Microsoft Office, including Outlook, Word, Excel, PowerPoint, and MS Teams.
- Excellent written and verbal communication skills.
- Ability to prioritize and navigate ambiguity with minimal oversight in a fast-paced environment.
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 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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