Job Title: Quality Assurance Senior Associate
Location: Holly Springs, North Carolina (On-Site)
Job Summary: We are supporting a highly regulated manufacturing environment with an opportunity for a Quality Assurance Senior Associate focused on real-time quality oversight and strong GMP compliance. This position plays a key part in supporting new product introduction, driving timely quality decisions, and partnering closely with manufacturing and support teams to maintain high standards across operations.
Responsibilities:
- Provide quality oversight to support manufacturing, testing, storage, and distribution in line with cGMP, GDP, and applicable regulations.
- Review and approve cGMP processes, procedures, documents, and records, including deviations, investigations, CAPAs, change controls, and validations.
- Support new product introduction activities across facilities, utilities, equipment, systems, and processes, including support for commissioning, qualification, validation, and new document development.
- Oversee on-the-floor analytical testing, assess quality risks, and support audits, inspections, and continuous improvement efforts.
Required:
- High school/GED plus 4 years of work experience, Associate degree plus 2 years of work experience, Bachelor’s degree plus 6 months of work experience, or a Master’s degree.
- Strong cGMP and GDP behaviors.
- Experience in biotechnology, or knowledge and process experience within a cGMP manufacturing facility or other highly regulated environment.
- Technical understanding of upstream and/or downstream manufacturing within a biotechnology production operation.
- Proficient Microsoft Office skills and knowledge of electronic systems such as EBR/MES, Delta V, and electronic quality systems.
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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