Job Title: Senior Quality Assurance Associate
Location: Holly Springs, North Carolina (On-site)
Job Summary: We are seeking a detail-oriented professional to provide direct quality oversight for bulk drug substance manufacturing and new product introductions. Our team relies on this position to facilitate real-time quality decisions, ensuring compliance with current Good Manufacturing Practices and supporting collaboration between Manufacturing and Quality teams.
Responsibilities:
- Oversee ongoing quality activities including facilities, equipment, documentation, and processes in alignment with current Good Manufacturing Practices and Good Documentation Practices.
- Drive completion and review of cGMP documentation such as deviations, investigations, corrective and preventative actions, change control records, and validations.
- Ensure production and testing records are accurately maintained and guide on-the-floor analytical testing efforts.
- Provide quality support during audits and inspections and identify opportunities for continuous improvement within existing processes and systems.
Required:
- Background in Manufacturing and Plant Quality Assurance (PQA) operations within a GMP facility.
- Ability and flexibility to work a stable shift schedule (including weekends and possibly nights) and to gown and work on the manufacturing floor.
- Demonstrated teamwork skills and capacity to quickly contribute in a fast-paced environment.
- Meet one of the following education/experience requirements: High school diploma or GED plus four years’ relevant work experience, Associate degree plus two years’ experience, Bachelor’s degree plus six months’ experience or Master’s degree.
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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