Quality Assurance Specialist

Quality Assurance Specialist – 3rd Shift

The Quality Assurance Specialist – 3rd Shift provides day-to-day technical, quality, and operational support to pharmaceutical manufacturing operations. This role ensures that production activities comply with cGMP standards, regulatory expectations, and safety requirements while supporting efficient, high-quality output in a fast-paced, highly regulated environment.

• Provide floor-level technical support to manufacturing operators and supervisors during 3rd shift operations.
• Troubleshoot equipment issues, process deviations, and workflow bottlenecks to maintain consistent production performance.
• Monitor production activities and assist with implementing corrective and preventive actions to address quality and operational concerns.
• Prepare, revise, and maintain GMP documentation, including standard operating procedures (SOPs), batch records, and logbooks.
• Ensure adherence to FDA and other global regulatory requirements across all manufacturing processes.
• Support investigations, develop CAPAs, and participate in change control processes to drive continuous improvement and compliance.
• Perform data collection, review, and analysis to verify compliance with cGMP and to identify opportunities for process optimization.
• Partner with Process Control teams to support equipment qualification and validation activities.
• Assist with process improvements, optimization initiatives, and technology transfers within manufacturing operations.
• Support coordination of preventive and corrective maintenance activities with Engineering and Maintenance departments.
• Train manufacturing personnel on procedures, new equipment, and process changes to promote consistent and compliant operations.
• Act as a subject matter liaison between Production, Quality, and Maintenance teams to ensure alignment on quality and operational standards.
• Uphold and promote a strong culture of safety and compliance on the production floor and within controlled environments.
• Support environmental monitoring and compliance activities as needed to maintain cleanroom and controlled area standards.
• Perform quality checks, inspections, and audit-related activities to verify product and process conformance to established specifications.

• 1–3+ years of experience in pharmaceutical, biotech, or other regulated manufacturing environments.
• Working knowledge of cGMP, GDP, and applicable regulatory guidelines.
• Strong analytical and problem-solving skills for technical troubleshooting and issue resolution.
• Excellent communication skills for clear interaction with cross-functional teams and documentation of activities.
• Strong documentation skills for accurate completion and maintenance of GMP records and reports.
• Ability to work effectively in a fast-paced, highly regulated manufacturing environment.
• Demonstrated attention to detail and accuracy in all quality-related tasks.
• Technical troubleshooting capabilities for equipment, process, and workflow issues.
• Collaboration and cross-functional communication skills to work effectively with Production, Quality, Engineering, and Maintenance.
• Effective time management and prioritization skills to handle multiple tasks and shifting priorities.
• Continuous improvement mindset focused on enhancing quality, efficiency, and compliance.
• Strong compliance and quality focus, with commitment to regulatory and safety standards.
• Experience with quality assurance, quality control, quality checks, inspection, and environmental monitoring.

• Experience in sterile or aseptic operations and biologics manufacturing is preferred.
• Knowledge of Six Sigma or other continuous improvement methodologies is an advantage.
• Familiarity with batch records, inventory management systems, and laboratory information management systems (LIMS) is beneficial.
• Experience supporting audits and participating in quality-related inspections.
• Ability to train and coach manufacturing personnel on procedures and process changes.
• Comfort working in clean rooms and controlled environments with strict compliance requirements.

This role is primarily on-site in pharmaceutical…