Job Title: Specialist Quality Control
Location: Holly Springs, North Carolina (On-site)
Job Summary: We are seeking a dedicated professional to support quality systems and QC laboratory operations within a GMP-regulated biotech or pharmaceutical environment. Our team counts on strong investigative leadership and collaboration skills to ensure key quality records and change controls are driven to successful closure.
Responsibilities:
- Own deviation records and manage change control tasks and deliverables within the DQMS Veeva System.
- Lead investigation teams, collect, and report metrics for the systems team while supporting startup of a GMP QC laboratory.
- Author, revise, and review a range of documents, including SOPs, test methods, safety assessments, and validation summary reports.
- Mentor new deviation owners and collaborate with cross-functional teams to support ongoing quality and compliance activities.
Required:
- 5 or more years of industry experience within a GMP-regulated biotech or pharmaceutical environment (alternatively: Doctorate degree; or Masters degree and 2 years of experience; or Bachelors degree and 4 years of experience; or Associates degree and 8 years of experience; or High school diploma / GED and 10 years of experience, as specified).
- Strong knowledge of quality systems and QC laboratory operations, including proven ability to write, own, and close quality records such as deviations, CAPAs, and change controls.
- Demonstrated excellence in written communication, grammar, and investigative leadership skills in a fast-paced, dynamic environment.
- Experience collaborating with cross-functional teams, leading meetings, and independently driving investigations to completion; experience with Veeva Quality Systems is highly desirable.
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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