Job Title: Quality Assurance Specialist
Location: Holly Springs, North Carolina (On-Site)
Job Summary: We are seeking a skilled professional to support quality oversight activities related to raw material inspection, sampling, testing, and Commissioning, Qualification & Validation (CQV) initiatives. Our team ensures adherence to cGMP regulations and collaborates cross-functionally to maintain the highest standards of quality within a fast-paced manufacturing environment.
Responsibilities:
- Oversee inspection, sampling, and testing of raw materials, including biobags, tubing, filters, chemicals, and related manufacturing components.
- Review batch records, inspection records, testing results, and GMP documentation for accuracy and compliance.
- Provide quality assurance oversight for Commissioning, Qualification, and Validation (CQV) activities in facilities, utilities, equipment, computerized systems, and manufacturing processes.
- Initiate and manage deviations, CAPAs, SOPs, controlled documents, and support continuous improvement and regulatory audit readiness.
Required:
- Bachelor’s degree with 5+ years of experience preferred, or an equivalent combination of education and experience in pharmaceutical, biotechnology, or regulated manufacturing environments.
- Strong knowledge of GMP, GDP, quality systems, and regulatory requirements including FDA and EMA guidelines.
- Experience supporting Commissioning, Qualification, Validation (CQV), and/or Computer System Validation (CSV) activities.
- Demonstrated competencies in raw material inspection, sampling, testing, and quality assurance review activities, familiarity with Raman technology and material identification testing preferred.
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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