Job Title: Quality Assurance Specialist
Location: Holly Springs, North Carolina (On-Site)
Job Summary: We are recruiting for a Quality Assurance Specialist opportunity supporting facility and utility quality oversight within a GMP-regulated environment. This position plays a key role in release activities, documentation review, and quality guidance across commissioning, qualification, validation, and ongoing operational support.
Responsibilities:
- Provide quality oversight for facility and utility release activities, including review and approval of procedures, protocols, change controls, and reports.
- Support troubleshooting efforts for utility systems and contribute quality guidance during commissioning, qualification, and validation testing.
- Author, review, and approve controlled documents such as SOPs, validation protocols, validation reports, work instructions, and forms.
- Oversee quality records including deviations, CAPAs, change controls, and work orders to help ensure compliance with GMP, GDP, safety, and control requirements.
Required:
- Doctorate degree, or Master degree with 3 years of experience, or Bachelor degree with 5 years of experience, or Associate degree with 10 years of experience, or high school diploma/GED with 12 years of experience.
- 5–10 years of experience is expected for the top must-have skill set profile.
- Biotech or pharmaceutical industry experience is required.
- Experience and knowledge in commissioning, qualification, and validation, including utility systems validation for WFI, USP, clean steam, clean air, and compressed gases.
- Strong understanding of regulatory requirements and industry standards, with the ability to provide sound quality guidance and make data-driven, risk-based decisions.
- Demonstrated attention to detail, accuracy in GMP documentation, and ability to communicate updates to senior management and follow assignments through to completion.
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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