Senior Quality Assurance Specialist

Overview

This senior-level Quality Assurance professional will play a key role in supporting site quality programs and daily GMP operations during second shift. The position partners closely with Quality leadership and cross-functional teams to ensure consistent compliance, sound decision-making, and timely execution across manufacturing activities.

The role requires a strong floor presence, sound judgment in deviation scenarios, and the ability to operate independently while influencing outcomes without direct authority. This individual will also act as a mentor to junior QA staff on shift and help reinforce a culture of accountability, precision, and continuous improvement.

Job Responsibilities

• Review, assess, and approve GMP documentation including manufacturing records, material-related documentation, quality events, validation records, and change activities
• Provide on-floor QA oversight to confirm adherence to procedures and regulatory expectations
• Lead or support investigations related to process, equipment, or documentation discrepancies and contribute to root cause analysis and corrective actions
• Balance production timelines with quality requirements, escalating risks as needed
• Perform electronic and physical release of materials, consumables, media, and related items
• Manage and maintain reference sample activities
• Support batch record review and final disposition activities
• Oversee site support programs in collaboration with facilities and engineering teams
• Serve as a quality mentor and resource for QA staff working the same shift
• Make preliminary assessments during deviations, including product impact and containment actions
• Participate in cross-functional problem solving using risk assessment and investigation tools
• Promote safe work practices and ensure alignment with SOPs, compliance standards, and site expectations
• Utilize electronic quality and manufacturing systems to ensure data integrity and traceability
• Track, trend, and analyze quality events to identify recurring issues and process variability
• Manage multiple priorities effectively in a fast-paced GMP environment

Job Qualifications

• Bachelor’s degree required; scientific discipline preferred
• Extensive experience in regulated manufacturing environments (GMP)
• Several years of direct Quality Assurance oversight within manufacturing operations
• Demonstrated experience working with quality systems such as deviations, CAPA, documentation control, and change management
• Strong understanding of regulatory expectations related to batch review and product disposition
• Proven ability to communicate clearly and effectively across functions
• Hands-on experience with computerized manufacturing and quality systems and standard data analysis tools
• Experience supporting aseptic manufacturing operations
• Exposure to manual inspection or product quality evaluation activities