Job Title: Quality Assurance Senior Associate
Location: West Greenwich, Rhode Island (On-site)
Job Summary: We are seeking a dedicated professional to support our team in providing on-the-floor quality oversight for bulk drug substance operations. Our team values proactive collaboration and decision-making to ensure all activities meet current Good Manufacturing Practices (cGMP) and regulatory standards.
Responsibilities:
- Provide quality oversight for Facilities & Engineering, Incoming Quality Assurance (IQA) Warehouse areas, and Process Development Laboratories.
- Review and approve GMP documentation including work orders, job plans, logbooks, and Manufacturing Execution System (MES) records.
- Ensure compliance of facilities, equipment, materials, and operations with cGMP and regulatory requirements.
- Maintain a presence in cleanroom areas and communicate effectively across departments to complete quality-related tasks.
Required:
- High school diploma/GED with 4 years work experience, Associate degree with 2 years work experience, Bachelor’s degree with 6 months work experience, or Master’s degree.
- Minimum of 2 years of experience in Quality or Manufacturing with exposure to Facilities & Engineering activities.
- Strong understanding of cGMP principles and regulatory expectations.
- Demonstrated experience utilizing enterprise systems such as Maximo, OEFM, MES, and Veeva Vault (CDOCS/DQMS) for quality oversight and documentation management.
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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