Job Title: Quality Control Specialist
Location: Holly Springs, North Carolina (On-Site)
Job Summary: We are seeking a Quality Control Specialist to support a GMP QC laboratory startup and help drive quality record closure across deviation and change control activities. Our team is looking for someone who can work collaboratively across Quality Control and Quality Assurance, communicate clearly, and lead investigations with minimal oversight.
Responsibilities:
- Own deviation records and manage change control tasks and deliverables.
- Lead investigation teams and help collect and report metrics for the systems team.
- Support authoring, revising, and reviewing SOPs, test methods, safety assessments, trend reports, qualification/validation summary reports, and technical reports.
- Assist with review of validation documents to support equipment and computerized system onboarding, and mentor new deviation owners as needed.
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 ability to write, own, and drive closure of quality records, including deviations, CAPAs, and change controls.
- Excellent written communication, grammar, and investigative leadership skills, with the ability to manage shifting priorities and work with minimal oversight.
- Experience working independently to lead meetings and push investigations through to completion.
- Must be able to support routine activities over weekends and public holidays as required.
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.
By applying for this job, you agree to receive calls, AI-generated calls, text messages, or emails from SSi People and its affiliates, and contracted partners. Frequency varies for text messages. Message and data rates may apply. Carriers are not liable for delayed or undelivered messages. You can reply STOP to cancel and HELP for help. You can access our privacy policy here: SSi People Privacy Policy