Job Title: Quality Control Specialist
Location: Holly Springs, North Carolina (On-Site)
Job Summary: We are supporting a company seeking a Quality Control Specialist to join the Quality Control Deviation and Change Control team during startup. Our team is looking for a detail-oriented professional who can own quality records, support QC laboratory operations, and help drive investigations and documentation to closure in a fast-paced GMP environment.
Responsibilities:
- Author and own change control records and deviations within the DQMS Veeva system.
- Lead investigation teams and support the collection and reporting of metrics for the systems team.
- Assist with review of validation documents to support equipment and computerized system onboarding.
- Author, revise, and review SOPs, test methods, safety assessments, trend reports, qualification/validation summary reports, and technical reports.
Required:
- At least 5 years of industry experience within a GMP-regulated biotech or pharmaceutical environment.
- Strong knowledge of quality systems and QC laboratory operations.
- Proven experience writing, owning, and driving closure of deviations, CAPAs, and change controls.
- Excellent written communication, grammar, and investigative leadership skills.
- Ability to collaborate with cross-functional teams, lead meetings, and drive investigations independently 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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