Quality Control Senior Associate

About the role

The Quality Control Senior Associate supports a GMP-regulated biotech and pharmaceutical facility by leading deviation investigations, managing change controls, and supporting the startup and ongoing operations of a Quality Control (QC) laboratory. This on-site role at the Holly Springs, NC facility follows a standard weekday schedule from 8:00 a.m. to 5:00 p.m., with flexible start times between 7:00 a.m. and 9:00 a.m. The position requires strong knowledge of quality systems, QC laboratory operations, and electronic quality management systems, along with excellent written communication and investigative leadership skills. The successful candidate will work in a fast-paced environment, collaborate closely with cross-functional teams, and independently drive quality records and investigations through to completion. The role is based in a modern GMP facility in Holly Springs, NC (with the contract position located in Apex, NC) and involves working closely with Quality, Quality Assurance, and other cross-functional teams in a laboratory setting that adheres to strict GMP and FDA regulatory requirements.

Responsibilities

• Lead and own deviation investigations within a GMP-regulated QC laboratory, including root cause analysis, impact assessment, and implementation of effective corrective and preventive actions (CAPAs).
• Author, manage, and drive closure of quality records, including deviations, CAPAs, and change controls, ensuring timely and compliant documentation.
• Work collaboratively with Quality and Quality Assurance teams to author and own change control records and deviations in the DQMS Veeva Quality System.
• Lead cross-functional investigation teams, facilitate discussions, and ensure investigations progress efficiently and are completed to a high standard of quality and compliance.
• Collect, analyze, and report metrics related to deviations, CAPAs, and change controls for the Quality Control Deviation and Change Control team.
• Support the startup of a GMP QC laboratory, including establishing processes, documentation, and systems needed for compliant operations.
• Support routine QC laboratory activities, including those that may occur over weekends and public holidays, to ensure continuity of operations and timely completion of investigations and quality system tasks.
• Ensure all laboratory activities, documentation, and quality processes comply with GMP (Good Manufacturing Practices), FDA expectations, and other applicable regulatory requirements.
• Support equipment qualification activities by helping verify that laboratory instruments and systems are properly installed, operating as intended, and suitable for their intended use before supporting GMP testing.
• Utilize Veeva Vault Quality Systems to efficiently author, manage, and track deviations, CAPAs, change controls, and other quality records within a compliant electronic quality management system.
• Collaborate with cross-functional stakeholders to evaluate proposed changes to equipment, processes, methods, and systems, ensuring change control management prevents introduction of quality or compliance risks.
• Apply practical QC laboratory experience to understand testing workflows, operational challenges, and compliance requirements, and use this knowledge to support investigations and continuous improvement.
• Demonstrate proactive ownership of assigned tasks, manage shifting priorities in a fast-paced environment, and complete work with minimal oversight.
• Lead and participate in meetings related to deviations, change controls, and quality issues, clearly communicate findings, and drive alignment on corrective actions and next steps.
• Maintain high standards of written communication and grammar in all quality documentation, ensuring clarity, completeness, and regulatory readiness.

Requirements

• At least 3 years of industry experience within a GMP-regulated biotech or pharmaceutical environment.
• Strong knowledge of quality systems and QC laboratory operations in a GMP setting.
• Proven ability to write, own, and drive closure of quality records, including deviations, CAPAs, and change controls.
• Demonstrated experience leading deviation investigations, including root cause analysis and impact assessment.
• Experience supporting or conducting change control management for equipment, processes, methods, and systems.
• Hands-on QC laboratory experience with understanding of testing workflows, documentation practices, and compliance requirements.
• Familiarity with GMP (Good Manufacturing Practices) and FDA regulatory expectations for pharmaceutical manufacturing and QC laboratories.
• Experience supporting equipment qualification activities to ensure instruments and systems are fit for intended use in GMP testing.
• Excellent written communication skills, including strong grammar and documentation practices.
• Strong investigative leadership skills, with the ability to lead cross-functional teams and drive investigations to completion.
• Detail-oriented and proactive approach, with the ability to manage shifting priorities in a fast-paced environment.
• Ability to work with minimal oversight while maintaining high standards of quality and compliance.
• Confidence in leading meetings and presenting investigation findings to cross-functional stakeholders.

Qualifications

• Experience with Veeva Vault Quality Systems or similar